Center for Biologics Evaluation and Research (U.S.)
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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 Biddle Law Library - University of Pennsylvania Law School.
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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 Biddle Law Library - University of Pennsylvania Law School.
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- Center for Biologics Evaluation and Research (U.S.)
- Authority link
- http://id.loc.gov/authorities/names/n88098944
25 Items by the Organization Center for Biologics Evaluation and Research (U.S.)
1 Items that are about the Organization Center for Biologics Evaluation and Research (U.S.)
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- Guidance for industry : M4, organization of the CTD
- Guidance for industry : adverse reactions section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : available therapy
- Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling
- Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format
- Guidance for industry : computerized systems used in clinical trials
- Guidance for industry : development and use of risk minimization action plans
- Guidance for industry : financial disclosure by clinical investigators
- Guidance for industry : good pharmacovigilance practices and pharmacoepidemiologic assessment
- Guidance for industry : how to complete the vaccine adverse event reporting system form (VAERS-1)
- Guidance for industry : information program on clinical trials for serious or life-threatening diseases and conditions
- Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims
- Guidance for industry : premarketing risk assessment
- 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 : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors
- Guidance for industry : somatic cell therapy for cardiac disease
- 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 : use of sterile connecting devices in blood bank practices
- REPORT TO THE BIOLOGICS COMMUNITY... U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES... 1998
- 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
- REPORT TO THE BIOLOGICS COMMUNITY... U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES... 1999
- Guidance for industry : M2, eCTD specification, questions & answers and change requests
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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/25IEGaJ15B4/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.law.upenn.edu/resource/25IEGaJ15B4/">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.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>
