FDA s Drug Review Process and the Package Label

Written By Tom Brody
FDA s Drug Review Process and the Package Label
  • Publsiher : Academic Press
  • Release : 13 December 2017
  • ISBN : 0128146486
  • Pages : 670 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled FDA s Drug Review Process and the Package Label written by Tom Brody which was release on 13 December 2017, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

FDA s Drug Review Process and the Package Label

FDA s Drug Review Process and the Package Label
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2017-12-13
  • Total pages : 670
  • ISBN : 0128146486
GET BOOK

Summary : FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of ...

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  • Publisher : Unknown
  • Release Date : 1973
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  • ISBN : 0128146486
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Summary : Download or read online FDA Annual Report written by United States. Food and Drug Administration, published by which was released on 1973. Get FDA Annual Report Books now! Available in PDF, ePub and Kindle....

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Summary : Download or read online Reauthorization of the Prescription Drug User Fee Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, published by which was released on 2008. Get Reauthorization of the Prescription Drug User Fee Act Books now! Available in PDF, ePub and Kindle....

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Summary : Download or read online National Journal Reports written by , published by which was released on 1975. Get National Journal Reports Books now! Available in PDF, ePub and Kindle....

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Summary : Hearing on technological advances in the field of medical devices from the perspective of the Food & Drug Admin. (FDA), as well as from patients & providers. Witnesses: Michael Friedman, Bruce Burlington, & Susan Alpert, FDA; John F. Hansbrough, Dir. of the Regional Burn Center, UCSD Medical Center; C. Warren Olanow, Chairman, Dept. ...