Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987
Resource Information
The event Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987 represents a publication, printing, distribution, issue, release or production of resources found in Indiana State Library.
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Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987
Resource Information
The event Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987 represents a publication, printing, distribution, issue, release or production of resources found in Indiana State Library.
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- Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987
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- 1987
8 Items that share the ProviderEvent Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987
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Context of Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987Publication of
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- 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 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 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 on formatting, assembling, and submitting new drug and antibiotic applications
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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/HMGPf5tFeV8/" typeof="PublicationEvent http://bibfra.me/vocab/lite/ProviderEvent"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.in.gov/resource/HMGPf5tFeV8/">Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987</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/HMGPf5tFeV8/" typeof="PublicationEvent http://bibfra.me/vocab/lite/ProviderEvent"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.in.gov/resource/HMGPf5tFeV8/">Rockville, Md., Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987</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>
