TY - BOOK ID - 50195693 TI - FDA's drug review process and the package label PY - 2017 SN - 0128146486 0128146478 9780128146484 9780128146477 PB - Cambridge, MA DB - UniCat KW - Drug approval KW - Safety regulations KW - United States. KW - Approval of drugs KW - Approval of new drugs KW - Drug approval process KW - New drug approval KW - Pharmaceutical policy KW - FDA KW - F.D.A. KW - U.S. Food & Drug Administration KW - AB KW - ABSh KW - Ameerika Ühendriigid KW - America (Republic) KW - Amerika Birlăshmish Shtatlary KW - Amerika Birlăşmi Ştatları KW - Amerika Birlăşmiş Ştatları KW - Amerika ka Kelenyalen Jamanaw KW - Amerika Qūrama Shtattary KW - Amerika Qŭshma Shtatlari KW - Amerika Qushma Shtattary KW - Amerika (Republic) KW - Amerikai Egyesült Államok KW - Amerikanʹ Veĭtʹsėndi͡avks Shtattn KW - Amerikări Pĕrleshu̇llĕ Shtatsem KW - Amerikas Forenede Stater KW - Amerikayi Miatsʻyal Nahangner KW - Ameriketako Estatu Batuak KW - Amirika Carékat KW - AQSh KW - Ar. ha-B. KW - Arhab KW - Artsot ha-Berit KW - Artzois Ha'bris KW - Bí-kok KW - Ē.P.A. KW - EE.UU. KW - Egyesült Államok KW - ĒPA KW - Estados Unidos KW - Estados Unidos da América do Norte KW - Estados Unidos de América KW - Estaos Xuníos KW - Estaos Xuníos d'América KW - Estatos Unitos KW - Estatos Unitos d'America KW - Estats Units d'Amèrica KW - Ètats-Unis d'Amèrica KW - États-Unis d'Amérique KW - Fareyniḳṭe Shṭaṭn KW - Feriene Steaten KW - Feriene Steaten fan Amearika KW - Forente stater KW - FS KW - Hēnomenai Politeiai Amerikēs KW - Hēnōmenes Politeies tēs Amerikēs KW - Hiwsisayin Amerikayi Miatsʻeal Tērutʻiwnkʻ KW - Istadus Unidus KW - Jungtinės Amerikos valstybės KW - Mei guo KW - Mei-kuo KW - Meiguo KW - Mî-koet KW - Miatsʻyal Nahangner KW - Miguk KW - Na Stàitean Aonaichte KW - NSA KW - S.U.A. KW - SAD KW - Saharat ʻAmērik KW - SASht KW - Severo-Amerikanskie Shtaty KW - Severo-Amerikanskie Soedinennye Shtaty KW - Si͡evero-Amerikanskīe Soedinennye Shtaty KW - Sjedinjene Američke Države KW - Soedinennye Shtaty Ameriki KW - Soedinennye Shtaty Severnoĭ Ameriki KW - Soedinennye Shtaty Si͡evernoĭ Ameriki KW - Spojené obce severoamerick KW - Spojené staty americk KW - SShA KW - Stadoù-Unanet Amerika KW - Stáit Aontaithe Mheirice KW - Stany Zjednoczone KW - Stati Uniti KW - Stati Uniti d'America KW - Stâts Unîts KW - Stâts Unîts di Americhe KW - Steatyn Unnaneysit KW - Steatyn Unnaneysit America KW - SUA KW - Sŭedineni amerikanski shtati KW - Sŭedinenite shtati KW - Tetã peteĩ reko Amérikagua KW - U.S. KW - U.S.A. KW - United States of America KW - Unol Daleithiau KW - Unol Daleithiau America KW - Unuiĝintaj Ŝtatoj de Ameriko KW - US KW - USA KW - Usono KW - Vaeinigte Staatn KW - Vaeinigte Staatn vo Amerika KW - Vereinigte Staaten KW - Vereinigte Staaten von Amerika KW - Verenigde State van Amerika KW - Verenigde Staten KW - VS KW - VSA KW - Wááshindoon Bikéyah Ałhidadiidzooígí KW - Wilāyāt al-Muttaḥidah KW - Wilāyāt al-Muttaḥidah al-Amirīkīyah KW - Wilāyāt al-Muttaḥidah al-Amrīkīyah KW - Yhdysvallat KW - Yunaeted Stet KW - Yunaeted Stet blong Amerika KW - ZDA KW - Združene države Amerike KW - Zʹi͡ednani Derz͡havy Ameryky KW - Zjadnośone staty Ameriki KW - Zluchanyi͡a Shtaty Ameryki KW - Zlucheni Derz͡havy KW - ZSA KW - ABŞ KW - Amerikanʹ Veĭtʹsėndi͡avks Shtattnė KW - É.-U. KW - ÉU KW - Saharat ʻAmērikā KW - Spojené obce severoamerické KW - Spojené staty americké KW - Stáit Aontaithe Mheiriceá KW - Wááshindoon Bikéyah Ałhidadiidzooígíí UR - https://www.unicat.be/uniCat?func=search&query=sysid:50195693 AB - 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 -- ER -