FDA’s Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions – eBook

FDA’s Drug Review Process and the Package Label, (PDF) guidance to pharmaceutical companies for writing FDA-submissions, such as the BLA, NDA, Clinical Study Reports, and Investigator’s Brochures. The ebook provides guidance to medical writers for drafting FDA-submissions in a way more likely to encourage FDA reviewers to grant approval of the drug. In detail, the ebook reproduces data on safety and efficacy from one hundred different FDA-submissions (NDAs, BLAs). The ebook reproduces comments and complaints from FDA reviewers regarding data that are ambiguous, fragmentary, or that detract from the drug’s approvability, and the ebook reveals how sponsors surmounted FDA’s concerns and how sponsors succeeded in convincing FDA to grant approval of the drug. The ebook uses the most comprehensive and reliable 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 ebook included almost 80,000 pages from FDA’s Medical Reviews, FDA’s Clinical Pharmacology Reviews, and FDA’s Pharmacology Reviews, from one hundred different BLAs or NDAs for one hundred different drugs. Every chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and shows how the sponsor’s data supported that section of the package label.

• Shows 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, autoimmune diseases, metabolic diseases, and neurological diseases
• This ebook uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from BLAs and NDAs as published on FDA’s website at the time FDA gives approval to the drug

NOTE: The product only includes the ebook FDA’s Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions in PDF. No access codes are included.