rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: FDA's drug review process and the package label
    sub title: strategies for writing successful FDA submissions
  name:
    name part: Brody, Tom
    role:
      role term: creator
    role:
      role term: author.
  name:
    name part: ScienceDirect (Online service)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  genre: Internet Resources.
  genre: Charts.
  origin info:
    place:
      place term: mau
    date issued: 2017
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource
  abstract: 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.
  table of contents: 1. Introduction; 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
  note: Tom Brody.
  note: Includes bibliographical references and index.
  subject:
    geographic code: n-us---
  subject:
    name:
      name part: United States.
      name part: Food and Drug Administration.
  subject:
    name:
      name part: United States.
      name part: Food and Drug Administration
  subject:
    topic: Drug approval
    topic: Safety regulations
    geographic: United States
  subject:
    topic: Drug Approval
    topic: legislation & jurisprudence
  subject:
    topic: Drug Approval
    topic: organization & administration
  subject:
    topic: Médicaments
    topic: Autorisation de mise sur le marché
    topic: Sécurité
    topic: Règlements
    geographic: États-Unis
  subject:
    topic: BUSINESS & ECONOMICS
    topic: Infrastructure
  subject:
    topic: SOCIAL SCIENCE
    topic: General
  subject:
    geographic: United States
  classification: KF27
  classification: 363.19/46
  identifier: 9780128146484
  identifier: 0128146486
  identifier: 9780128146477
  identifier: 0128146478
  identifier: 9780128146484 Ingram Content Group
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: N$T
    record creation date: 171204
    record change date: 20260327152835.8
    record identifier: in00005762871
    language of cataloging:
      language term: eng