Drug approval -- Government policy -- United States
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The concept Drug approval -- Government policy -- United States represents the subject, aboutness, idea or notion of resources found in Biddle Law Library - University of Pennsylvania Law School.
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Drug approval -- Government policy -- United States
Resource Information
The concept Drug approval -- Government policy -- United States represents the subject, aboutness, idea or notion of resources found in Biddle Law Library - University of Pennsylvania Law School.
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- Drug approval -- Government policy -- United States
11 Items that share the Concept Drug approval -- Government policy -- United States
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- Reviewer guidance : conducting a clinical safety review of a new product application and preparing a report on the review
- Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013
- FDA's drug review process and the package label : strategies for writing successful FDA submissions
- Guidance for industry : M4, organization of the CTD
- Guidance for industry : M4E, the CTD, efficacy
- Guidance for industry : M4Q, the CTD, quality
- Guidance for industry : M4S, the CTD, safety
- Guidance for industry : M4S, the CTD, safety appendices
- Guidance for industry : formal meetings between the FDA and sponsors or applicants
- Guidance for industry : format and content for the CMC section of an annual report
- 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"
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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.law.upenn.edu/resource/Fgfmg1XQyS0/" typeof="CategoryCode http://bibfra.me/vocab/lite/Concept"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.law.upenn.edu/resource/Fgfmg1XQyS0/">Drug approval -- Government policy -- United States</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.law.upenn.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.law.upenn.edu/">Biddle Law Library - University of Pennsylvania Law School</a></span></span></span></span></div>
