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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

   Conduct Review of New Drug Application (NDA) or Biologics License Application (BLA) The review process takes place in six major steps. Each step will be described in detail later in this...

   • FDA's Drug Review Process: Continued

     Vertical Format: Click here for a high-resolution, printable...

   • GRPs

     A Good Review Practice, or GRP, is a “documented best...

2. www.fda.gov › drugs › information-consumers-and-patients-drugsFDA's Drug Review Process: Continued | FDA - U.S. Food and Drug...

   www.fda.gov › drugs › information-consumers-and-patients-drugs

   • Αποθηκευμένο αντίγραφο

   Vertical Format: Click here for a high-resolution, printable PDF (3.9 MB) of the infographic. Drug Review Steps Simplified. Preclinical (animal) testing. An investigational new drug...

3. www.fda.gov › drugs › guidance-compliance-regulatory-informationGood Review Practices | GRPs | FDA - U.S. Food and Drug...

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

   • Αποθηκευμένο αντίγραφο

   A Good Review Practice, or GRP, is a “documented best practice” within CDER that discusses any aspect related to the process, format, content and/or management of a product review.

4. 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)

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 analyses will not be inadvertently omitted.

6. www.fda.gov › patients › drug-development-processStep 4: FDA Drug Review | FDA - U.S. Food and Drug Administration

   www.fda.gov › patients › drug-development-process

   • Αποθηκευμένο αντίγραφο

   FDA Review. Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to...

7. fda.report › media › 72749Good Review Practice: Clinical Consultative Review of Drugs...

   fda.report › media › 72749

   This MAPP describes the clinical consultative review process in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), and supplemental NDAs and BLAs. The procedures in this MAPP are intended to ...