Center for Biologics Evaluation and Research (U.S.)
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Center for Biologics Evaluation and Research (U.S.)
Resource Information
The organization Center for Biologics Evaluation and Research (U.S.) represents an institution, an association, or corporate body that is associated with resources found in Indiana State Library.
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309 Items by the Organization Center for Biologics Evaluation and Research (U.S.)
3 Items that are about the Organization Center for Biologics Evaluation and Research (U.S.)
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- Annual performance report, Prescription Drug User Fee Act of 1992 fiscal year : ... report to Congress
- Annual reports for approved premarket approval applications (PMA)
- Assay migration studies for in vitro diagnostic devices
- Bundling multiple devices or multiple indications in a single submission
- Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products
- Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers
- Draft guidance for industry and FDA staff : technical considerations for pen, jet, and related injectors intended for use with drugs and biological products
- E2f development safety update report
- Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter
- Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter
- FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals
- FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
- FY ... performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997
- General principles of software validation : final guidance for industry and FDA staff
- Guidance for FDA reviewers : premarket notification submissions for blood and plasma warmers
- Guidance for FDA reviewers : premarket notification submissions for empty containers for the collection and processing of blood and blood components
- Guidance for FDA reviewers : premarket notification submissions for transfer sets (excluding sterile connecting sets)
- Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
- Guidance for GDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
- Guidance for clinical trial sponsors : establishment and operation of clinical trial data monitoring committees
- Guidance for clinical trial sponsors : on the establishment and operation of clinical trial data monitoring committees
- Guidance for indusry : integrated summary of effectiveness
- Guidance for industries : variances for blood collection from individuals with hereditary hemochromatosis
- Guidance for industry : "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type)
- Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms
- Guidance for industry : "lookback" for hepatitis c virus (HCV) : product quarantine, consignee notification, further testing, product disposition, and notification of transfusion recipients based on donor test results indicating infection with HCV
- Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation
- Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records
- Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms
- Guidance for industry : CGMP for phase 1 investigational drugs
- Guidance for industry : Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps)
- Guidance for industry : E 10 choice of control group and related issues in clinical trials
- Guidance for industry : E 10 choice of control group and related issues in clinical trials
- Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population
- Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers
- Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
- Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers
- Guidance for industry : E2BM data elements for transmission of individual case safety reports
- Guidance for industry : E2E pharmacovigilance planning
- Guidance for industry : E6 good clinical practice, consolidated guidance
- Guidance for industry : E9 statistical principles for clinical trials
- Guidance for industry : FDA export certificates
- Guidance for industry : FDA review of vaccine labeling requirements for warnings, use instructions, and precautionary information
- Guidance for industry : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer
- Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information
- Guidance for industry : M2 eCTD : electronic common technical document specification
- Guidance for industry : M2, eCTD specification, questions & answers and change requests
- Guidance for industry : M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals
- Guidance for industry : M4, organization of the CTD
- Guidance for industry : M4, the CTD, efficacy questions and answers
- Guidance for industry : M4, the CTD, general questions and answers
- Guidance for industry : M4E, the CTD, efficacy
- Guidance for industry : M4S, the CTD, safety
- Guidance for industry : M4S, the CTD, safety appendices
- Guidance for industry : MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry : Q10 pharmaceutical quality system
- Guidance for industry : Q1A(R2) stability testing of new drug substances and products
- Guidance for industry : Q1B photostability testing of new drug substances and products
- Guidance for industry : Q1C stability testing for new dosage forms
- Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products
- Guidance for industry : Q1E evaluation of stability data
- Guidance for industry : Q2B validation of analytical procedures, methodology
- Guidance for industry : Q3A impurities in new drug substances
- Guidance for industry : Q3A impurities in new drug substances
- Guidance for industry : Q3B(R2) impurities in new drug products
- Guidance for industry : Q3C impurities, residual solvents
- Guidance for industry : Q3C tables and list
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 1, Residue on ignition/sulphated ash general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 3, Test for particulate contamination : subdivisible particles general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 3, Test for particulate contamination : subdivisible particles general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 4A, Microbiological examination of nonsterile products : microbial enumeration tests general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 4B, Microbiological examination of nonsterile products : tests for specified microorganisms general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region, Annex 4C, Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter
- Guidance for industry : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
- Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products
- Guidance for industry : Q7A good manufacturing practice guidance for active pharmaceutical ingredients
- Guidance for industry : Q8 pharceutical development
- Guidance for industry : Q8(R2) pharmaceutical development
- Guidance for industry : Q9 quality risk management
- Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals
- Guidance for industry : S1C(R2) dose selection for carcinogenicity studies
- Guidance for industry : S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals
- Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals
- Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals
- Guidance for industry : S8 immunotoxicity studies for human pharmaceuticals
- Guidance for industry : SPL standard for content of labeling technical Qs & As
- Guidance for industry : accelerated approval products, submission of promotional materials
- Guidance for industry : acceptance of foreign clinical studies
- Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
- Guidance for industry : adequate and appropriate donor screening for hepatitis b : hepatitis b surface antigen (HBsAg) assays used to test donors of whole blood and blood components, including source plasma and source leukocytes
- Guidance for industry : adverse reactions section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : advisory committees : implementing Section 120 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry : aerosol steroid product safety information in prescription drug advertising and promotional labeling
- Guidance for industry : amendment (donor deferral for transfusion in France since 1980) to "Guidance for industry, revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products"
- Guidance for industry : an acceptable circular of information for the use of human blood and blood components
- Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation
- Guidance for industry : animal models : essential elements to address efficacy under the animal rule
- Guidance for industry : assay development for immunogenicity testing of therapeutic proteins
- Guidance for industry : assessing donor suitability and blood and blood product safety in cases of known or suspected west Nile virus infection
- Guidance for industry : availability of licensed donor screening tests labeled for use with cadaveric blood specimens
- Guidance for industry : available therapy
- Guidance for industry : bar code label requirements, questions and answers
- Guidance for industry : biological product deviation reporting for blood and plasma establishments
- Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components
- Guidance for industry : blood establishment computer system validation in the user's facility
- Guidance for industry : brief summary : disclosing risk information in consumer-directed print advertisements
- Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs)
- Guidance for industry : certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests
- Guidance for industry : changes to an approved application : biological products, human blood and blood components intended for transfusion or for further manufacture
- Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products
- Guidance for industry : characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases
- Guidance for industry : class II special controls guidance document : cord blood processing system and storage container
- Guidance for industry : class II special controls guidance document : in vitro HIV drug resistance genotype assay
- Guidance for industry : classifying resubmissions in response to action letters
- Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines
- Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines
- Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling
- Guidance for industry : clinical pharmacology section of labeling for human prescription drug and biological products : content and format
- Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : collection of race and ethnicity data in clinical trials
- Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information
- Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information
- Guidance for industry : complementary and alternative medicine products and their regulation by the Food and Drug Administration
- Guidance for industry : compliance with 21 CFR part 1271.150(c)(1), manufacturing arrangements
- Guidance for industry : computerized systems used in clinical trials
- Guidance for industry : considerations for allogeneic pancreatic islet cell products
- Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications
- Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications
- Guidance for industry : considerations for plasmid DNA vaccines for infectious disease indications
- Guidance for industry : consumer-directed broadcast advertisements
- Guidance for industry : consumer-directed broadcast advertisements, questions and answers
- Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
- Guidance for industry : container closure systems for packaging human drugs and biologics
- Guidance for industry : container closure systems for packaging human drugs and biologics, questions and answers
- Guidance for industry : content and format for geriatric labeling
- Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance for industry : contents of a complete submission for the evaluation of proprietary names
- Guidance for industry : cooperative manufacturing arrangements for licensed biologics
- Guidance for industry : criteria for safety and efficacy evaluation of oxygen therapeutics as red blood cell substitutes
- Guidance for industry : development and use of risk minimization action plans
- Guidance for industry : dosage and administration section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : drug-induced liver injury, premarketing clinical evaluation
- Guidance for industry : drug-induced liver injury, premarketing clinical evaluation
- Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
- Guidance for industry : efficacy studies to support marketing of fibrin sealant products manufactured for commercial use
- Guidance for industry : electronic signatures, scope and application, Part 11, electronic records
- Guidance for industry : eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry : environmental assessment of human drug and biologics applications
- Guidance for industry : errors and accidents regarding saline dilution of samples used for viral marker testing
- Guidance for industry : fast track drug development programs, designation, development and application review
- Guidance for industry : financial disclosure by clinical investigators
- Guidance for industry : formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP
- Guidance for industry : formal dispute resolution, appeals above the division level
- Guidance for industry : formal meetings between the FDA and sponsors or applicants
- Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
- Guidance for industry : gene therapy clinical trials, observing subjects for delayed adverse events
- Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases
- Guidance for industry : good pharmacovigilance practices and pharmacoepidemiologic assessment
- Guidance for industry : granularity document : annex to M4, organization of the CTD
- Guidance for industry : guidance for human somatic cell therapy and gene therapy
- Guidance for industry : how to complete the vaccine adverse event reporting system form (VAERS-1)
- Guidance for industry : how to comply with the Pediatric Research Equity Act
- Guidance for industry : implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997, elimination of certain labeling requirements
- Guidance for industry : implementation of acceptable full-length donor history questionnaire and accompanying materials for use in screening donors of blood and blood components
- Guidance for industry : implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies
- Guidance for industry : independent consultants for biotechnology clinical trial protocols
- Guidance for industry : indexing structured product labeling
- Guidance for industry : information program on clinical trials for serious or life-threatening diseases and conditions
- Guidance for industry : information request and discipline review letters under the prescription drug user fee act
- Guidance for industry : informed consent recommendations for source plasma donors participating in plasmapheresis and immunization programs
- Guidance for industry : integrated summaries of effectiveness and safety : location within the common technical document
- Guidance for industry : interpreting sameness of monoclonal antibody products under the orphan drug regulations
- Guidance for industry : labeling for human prescription drug and biological products, implementing the new content and format requirements
- Guidance for industry : manufacturing biological intermediates and biological drug substances using spore-forming microorganisms
- Guidance for industry : manufacturing, processing, or holding active pharmaceutical ingredients
- Guidance for industry : minimally manipulated, unrelated, allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution in patients with hematological malignancies
- Guidance for industry : monoclonal antibodies used as reagents in drug manufacturing
- Guidance for industry : nonclinical studies for the safety evaluation of pharmaceutical excipients
- Guidance for industry : notifying FDA of fatalities related to blood collection or transfusion
- Guidance for industry : nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV), testing, product disposition, and donor deferral and reentry
- Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products
- Guidance for industry : part 11, electronic records : electronic signatures--scope and application
- Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims
- Guidance for industry : pharmacogenomic data submissions
- Guidance for industry : pharmacogenomic data submissions, companion evidence
- Guidance for industry : population pharmacokinetics
- Guidance for industry : postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic
- Guidance for industry : postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : potency tests for cellular and gene therapy products
- Guidance for industry : pre-storage leukocyte reduction of whole blood and blood compoments intended for transfusion
- Guidance for industry : precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their contacts
- Guidance for industry : precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their intimate contacts
- Guidance for industry : premarketing risk assessment
- Guidance for industry : preparation of IDEs and INDs for products intended to repair or replace knee cartilage
- Guidance for industry : presenting risk information in prescription drug and medical device promotion
- Guidance for industry : process validation, general principles and practices
- Guidance for industry : product name placement, size, and prominence in advertising and promotional labeling
- Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
- Guidance for industry : providing clinical evidence of effectiveness for human drug and biological products
- Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Guidance for industry : providing regulatory submissions in electronic format, content of labeling
- Guidance for industry : providing regulatory submissions in electronic format, general considerations
- Guidance for industry : providing regulatory submissions in electronic format, general considerations
- Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports
- Guidance for industry : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling
- Guidance for industry : providing regulatory submissions in electronic format, receipt date
- Guidance for industry : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs)
- Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols
- Guidance for industry : public health issues posed by the use of nonhuman primate xenografts in humans
- Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
- Guidance for industry : quality systems approach to pharmaceutical CGMP regulations
- Guidance for industry : recognition and use of a standard for uniform blood and blood component container labels
- Guidance for industry : recommendations for assessment of donor suitability and blood and blood product safety in cases of possible exposure to anthrax
- Guidance for industry : recommendations for collecting red blood cells by automated apheresis methods
- Guidance for industry : recommendations for deferral of donors and quarantine and retrieval of blood and blood products in recent recipients of smallpox vaccine (vaccinia virus) and certain contacts of smallpox vaccine recipients
- Guidance for industry : recommendations for donor questioning regarding possible exposure to malaria
- Guidance for industry : recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from donors of human cells, tissues and cellular and tissue-based products (HCT/Ps)
- Guidance for industry : regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) : small entity compliance guide
- Guidance for industry : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry : requalification method for reentry of blood donors deferred because of reactive test results for antibody to hepatitis B core antigen (anti-HBc)
- Guidance for industry : revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products
- Guidance for industry : revised recommendations for donor and product management based on screening tests for syphilis
- Guidance for industry : revised recommendations for the assessment of donor suitability and blood product safety in cases of suspected severe acute respiratory syndrome (SARS) or exposure to SARS
- Guidance for industry : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors
- Guidance for industry : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency
- Guidance for industry : somatic cell therapy for cardiac disease
- Guidance for industry : source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans
- Guidance for industry : standards for securing the drug supply chain : standardized numerical identification for prescription drug packages
- Guidance for industry : sterile drug products produced by aseptic processing, current good manufacturing practice
- Guidance for industry : streamlining the donor interview process, recommendations for self-administered questionnaires
- Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
- Guidance for industry : submitting and reviewing complete responses to clinical holds
- Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations
- Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research
- Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
- Guidance for industry : supplemental testing and the notification of consignees of donor test results for antibody to hepatitis C virus (anti-HCV)
- Guidance for industry : testing limits in stability protocols for standardized grass pollen extracts
- Guidance for industry : toxicity grading schedule for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
- Guidance for industry : tropical disease priority review vouchers
- Guidance for industry : use of nucleic acid tests on pooled and individual samples from donors of whole blood and plasma components (including source plasma and source leukocytes) to adequately and appropriately reduce the risk of transmission of HIV-1 and HCV
- Guidance for industry : use of nucleic acid tests to reduce the risk of transmission of West Nile virus from donors of whole blood and blood components intended for transfusion and donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry : use of serological tests to reduce the risk of transmission of trypanosoma cruzi infection in whole blood and blood components for transfusion and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry : use of sterile connecting devices in blood bank practices
- Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products
- Guidance for industry : validation of procedures for processing of human tissues intended for transplantation
- Guidance for industry : warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products, content and format
- Guidance for industry : year 2000 date change for computer systems and software applications used in the manufacture of blood products
- Guidance for industry M2 : eCTD specification : questions & answers and change requests
- Guidance for industry and FDA review staff : collection of platelets by automated methods
- Guidance for industry and FDA staff : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle
- Guidance for industry and FDA staff : commercially distributed analyte specific reagents (ASRs), frequently asked questions
- Guidance for industry and FDA staff : expedited review of premarket submissions for devices
- Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use
- Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
- Guidance for industry and clinical investigators : the use of clinical holds following clinical investigator misconduct
- Guidance for industry and review staff : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information
- Guidance for industry and staff : minimal manipulation of structural tissue jurisdictional update
- Guidance for industry and staff : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA
- Guidance for industry for platelet testing and evaluation of platelet subsitute products
- Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use"
- Guidance for industry in the manufacture and clinical evaluation of in vitro tests to detect nucleic acid sequences of human immunodeficiency viruses types 1 and 2
- Guidance for industry on the content and format of chemistry, manufacturing and controls information and establishment description information for an allergenic extract or allergen patch test
- Guidance for industry, q & a : content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance for reviewers : potency limits for standardized dust mite and grass allergen vaccines, a revised protocol
- Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility
- Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria
- In vitro diagnostic (IVD) device studies, frequently asked questions
- Information sheet : guidance for institutional review boards and clinical investigators (non-local IRB review)
- Information sheet guidance for IRBs, clinical investigators, and sponsors : frequently asked questions about medical devices
- Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process
- PDUFA pilot project : proprietary name review
- PHS guideline on infectious disease issues in xenotransplantation
- Points to consider in the manufacture and testing of monoclonal antibody products for human use
- Premarket approval application filing review
- Premarket approval application modular review
- Premarket assessment of pediatric medical devices
- Proceedings of the Sixth International Symposium on Pertussis :
- Proceedings of the Sixth International Symposium on Pertussis, Jack Masur Auditorium, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, September 26-28, 1990
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 10, polyacrylamide gel electrophoresis general chapter
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 9, tablet friability general chapter
- Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter
- Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles
- Q8(R1) pharmaceutical development revision 1
- Real-time premarket approval application (PMA) supplements
- Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
- Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports
- S9 nonclinical evaluation for anticancer pharmaceuticals
- The Right choice : minority college & university program
- The Right choice : minority college & university program
- Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
- User fees and refunds for premarket approval applications
- User fees and refunds for premarket approval applications
- User fees and refunds for premarket notification submissions (510(k)s)
- A review of FDA's implementation of the Drug Export Amendments of 1986
- Animal models : essential elements to address efficacy under the animal rule
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Data Citation of the Organization Center for Biologics Evaluation and Research (U.S.)
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.library.in.gov/resource/2EFrHkjHIQU/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.in.gov/resource/2EFrHkjHIQU/">Center for Biologics Evaluation and Research (U.S.)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.library.in.gov/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.library.in.gov/">Indiana State Library</a></span></span></span></span></div>
