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1. www.fda.gov › drugs › development-approval-process-drugsGuidance Documents for Drug Applications | FDA

   www.fda.gov › drugs › development-approval-process-drugs

   • Αποθηκευμένο αντίγραφο

   These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design,...

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

   www.fda.gov › media › 78941

   The DRG is intended for use in the review of New Drug Applications ( NDAs), Biologics License Applications ( BLAs), and efficacy supplements.

3. www.fda.gov › regulatory-information › search-fda-guidance-documentsSearch for FDA Guidance Documents | FDA - U.S. Food and Drug...

   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,...

4. www.accessdata.fda.gov › drugsatfda_docs › ndaReview - Food and Drug Administration

   www.accessdata.fda.gov › drugsatfda_docs › nda

   9 Ιουλ 2021 · Federal Food, Drug, and Cosmetic Act (FDCA) for Kerendia (finerenone) tablets. This NDA provides for the use of Kerendia (finerenone) tablets to reduce the risk of sustained eGFR decline, end...

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

   www.accessdata.fda.gov › drugsatfda_docs › nda

   The Office of Clinical Pharmacology/ Division of Cardiometabolic and Endocrine Pharmacology (OCP/DCEP) has reviewed the Clinical Pharmacology information of NDA 212801, and concludes that the...

6. www.nejm.org › doi › fullFDA Regulation of Prescription Drugs | NEJM

   www.nejm.org › doi › full

   16 Φεβ 2017 · Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk...

7. www.accessdata.fda.gov › drugsatfda_docs › ndaReview - Food and Drug Administration

   www.accessdata.fda.gov › drugsatfda_docs › nda

   25 Ιουν 2020 · with an open-label extension study to assess the efficacy and safety of casimersen and golodirsen in patients with DMD. The study consists of a 96-week randomized, double-blind,...