000			03659cam a22004457i 4500
999			_c209323 _d209323
001			20595394
003			OSt
005			20220422112207.0
008			180723s2018 enkad b 001 0 eng d
010			_a 2017300270
020			_a9780128146477 (pbk.)
020			_a0128146478 (pbk.)
035			_a(OCoLC)on1001456623
040			_aBTCTA _beng _cUNZA _erda _dYDX _dBDX _dTXQ _dOCLCO _dLBRTY _dSLU _dOCLCF _dDLC
042			_alccopycat
050	0	0	_aR852.5 _bBRO 2018
082	0	0	_a615.1072/4 _223
100	1		_aBrody, Tom, _eauthor.
245	1	0	_aFDA's drug review process and the package label : _bstrategies for writing successful FDA submissions / _cTom Brody.
260			_aLondon, United Kingdom ; _aSan Diego, CA, United States : _bAcademic Press, _cc2018
264		4	_c©2018
300			_axvi, 653 pages : _billustrations, charts ; _c24 cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _2rdacarrier
504			_aIncludes index.
505	0		_a1. 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			_aFDA'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 -- _cSee back cover.
610	1	0	_aUnited States. _bFood and Drug Administration.
610	1	7	_aUnited States. _bFood and Drug Administration. _2fast _0(OCoLC)fst00549734
650		0	_aDrug approval _xGovernment policy _zUnited States.
650		0	_aClinical trials _zUnited States _xMoral and ethical conflicts.
650		0	_aDrug approval _xSafety regulations _zUnited States.
651		7	_aUnited States. _2fast _0(OCoLC)fst01204155
700	1		_aBrody, Tom, _eauthor.
906			_a7 _bcbc _ccopycat _d2 _encip _f20 _gy-gencatlg
942			_2lcc _cBOOK