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03167aam a2200301Ii 4500 001 A14A9F32580511E8A8F83C5097128E48 003 SILO 005 20180515010114 008 170818s2018 xxkad b 001 0 eng d 020 $a 0128146478 020 $a 9780128146477 035 $a (OCoLC)1001456623 040 $a BTCTA $b eng $e rda $c BTCTA $d YDX $d BDX $d TXQ $d OCLCO $d LBRTY $d SILO 050 4 $a R852.5 $b .B76 2018 100 1 $a Brody, Tom, $e author. 245 10 $a FDA's drug review process and the package label : $b strategies for writing successful FDA submissions / $c Tom Brody. 264 1 $a London, United Kingdom : $b Academic Press, $c [2018] 300 $a xvi, 653 pages : $b illustrations, charts ; $c 24 cm 505 0 $a 1. Introduction to regulated clinical trials -- 2. FDA's decision-making process when assessing ambiguous data -- 3. Food effect studies -- 4. Dose modification and dose titration -- 5. Contraindications -- 6. Animal studies -- 7. Drug-drug interactions: part one (small molecule drugs) -- 8. Drug-drug interactions: part two (therapeutic proteins) -- 9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions -- 10. Drug class analysis -- 11. Relatedness -- 12. Adjudication of clinical data -- 13. Coding -- 14. Pooling. 520 $a 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. See back cover. 610 10 $a United States. $b Food and Drug Administration. 650 0 $a Drug approval $x Government policy $z United States. 650 0 $a Clinical trials $z United States $x Moral and ethical conflicts. 650 0 $a Drug approval $x Safety regulations $z United States. 700 1 $a Brody, Tom, $e author. 941 $a 1 952 $l OVUX522 $d 20191210023437.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=A14A9F32580511E8A8F83C5097128E48Initiate Another SILO Locator Search