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1. www.fda.gov › media › 78941CDER 21st Century Review Desk Reference Guide - U.S. Food and...

   www.fda.gov › media › 78941

   Desk Reference Guide. New Drug Application and Biologics License Application Reviews (NDA/BLA Review Process) . Recent Major Changes. • Changes to accommodate expedited review of...

2. www.fda.gov › drugs › guidance-compliance-regulatory-informationGuidances | Drugs | FDA - U.S. Food and Drug Administration

   www.fda.gov › drugs › guidance-compliance-regulatory-information

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   Find a guidance related to drugs. Go to Search for FDA Guidance Documents; Scroll down to Guidance Document Search; Filter by FDA Organization, Center for Drug Evaluation and Research; Use...

3. www.fda.gov › regulatory-information › search-fda-guidance-documentsSearch for FDA Guidance Documents

   www.fda.gov › regulatory-information › search-fda-guidance-documents

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   The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product,...

4. www.fda.gov › media › 72259Good Review Management Principles and Practices for New Drug ...

   www.fda.gov › media › 72259

   126 FDA’s goal is to execute an effective, efficient, and thorough review process that ensures high- 127 quality regulatory decisions. The following operational principles are essential...

5. www.accessdata.fda.gov › drugsatfda_docs › ndaCENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug...

   www.accessdata.fda.gov › drugsatfda_docs › nda

   REQUIRED PEDIATRIC ASSESSMENTS. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations),...

6. www.accessdata.fda.gov › drugsatfda_docs › ndaClinical Pharmacology Review(s) - Food and Drug Administration

   www.accessdata.fda.gov › drugsatfda_docs › nda

   1. EXECUTIVE SUMMARY. The applicant submitted this original New Drug Application (NDA) for the treatment of patients with Cushing’s disease. Osilodrostat is an inhibitor of 11 beta-hydroxylase...

7. www.accessdata.fda.gov › drugsatfda_docs › ndaCENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug...

   www.accessdata.fda.gov › drugsatfda_docs › nda

   25 Μαΐ 2023 · FDA has published a draft guidance, Material Threat Medical Countermeasure Priority Review . 2 We update guidances periodically. For the most recent version of a guidance, check the FDA...