Center for Drugs and Biologics (U.S.)
Resource Information
The organization Center for Drugs and Biologics (U.S.) represents an institution, an association, or corporate body that is associated with resources found in Indiana State Library.
The Resource
Center for Drugs and Biologics (U.S.)
Resource Information
The organization Center for Drugs and Biologics (U.S.) represents an institution, an association, or corporate body that is associated with resources found in Indiana State Library.
- Label
- Center for Drugs and Biologics (U.S.)
- Authority link
- (EG-IN)906597
20 Items by the Organization Center for Drugs and Biologics (U.S.)
Context
Context of Center for Drugs and Biologics (U.S.)Contributor of
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- Approved drug products with therapeutic equivalence evaluations
- Approved drug products with therapeutic equivalence evaluations
- Compliance program reference : inspections of licensed and unlicensed blood banks (compliance program #7342.001) and inspections of source plasma establishments (compliance program #7342.002)
- Compliance program reference : otc drug monograph implementation (compliance program #7361.003)
- Forskolin : its biological and chemical properties
- Guideline for submitting documentation for packaging for human drugs and biologics
- Guideline for submitting documentation for the manufacture of and controls for drug products
- Guideline for submitting documentation for the stability of human drugs and biologics
- Guideline for submitting samples and analytical data for methods validation
- Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
- Guideline for the format and content of the chemistry, manufacturing, and controls section of an application
- Guideline for the format and content of the human pharmacokinetics and bioavailability section of an application
- Guideline for the format and content of the microbiology section of an application
- Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application
- Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application
- Guideline for the format and content of the summary for new drug and antibiotic applications
- Guideline for the submission in microfiche of the archival copy of an application
- Guideline on formatting, assembling, and submitting new drug and antibiotic applications
- Guideline on general principles of process validation
- Guideline on sterile drug products produced by aseptic processing
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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/Pp4V0uRhSm8/" 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/Pp4V0uRhSm8/">Center for Drugs and Biologics (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>
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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/Pp4V0uRhSm8/" 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/Pp4V0uRhSm8/">Center for Drugs and Biologics (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>
