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1. www.fda.gov › media › 87621Good Review Practice: Clinical Review of Investigational New Drug...

   www.fda.gov › media › 87621

   This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND)

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

   www.fda.gov › media › 72259

   21 The purpose of this guidance is to provide recommendations to industry and review staff on good 22 review management principles and practices (GRMPs) for the review of new drug...

3. fda.report › media › 132157Guidance for Review Staff and Industry Good Review Management ...

   fda.report › media › 132157

   This document provides guidance to industry and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on good review management principles and practices (GRMPs) for the conduct of the first cycle

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

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

   • Αποθηκευμένο αντίγραφο

   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,...

5. fda.report › media › 71665Reviewer Guidance - fda.report

   fda.report › media › 71665

   This good review practice (GRP) guidance is intended to assist reviewers conducting the clinical safety reviews as part of the NDA and BLA review process, provide standardization and consistency in the format and content of safety reviews, and ensure that critical presentations and

6. 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),...

7. 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...