FDA s Drug Review Process and the Package Label

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. Reveals 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, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Produk Detail:

  • Author : Tom Brody
  • Publisher : Academic Press
  • Pages : 670 pages
  • ISBN : 0128146486
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKFDA s Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release : 13 December 2017
GET THIS BOOKFDA's Drug Review Process and the Package Label

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

Essentials of Pharmacy Law

Essentials of Pharmacy Law
  • Author : Douglas J. Pisano
  • Publisher : CRC Press
  • Release : 29 July 2002
GET THIS BOOKEssentials of Pharmacy Law

This book examines the laws and regulations relating to the practice of pharmacy, and the regulation and control of drugs cosmetics, and medical devices. Most available pharmacy law texts thus far have been written by lawyers and present heavy, dense, legalistic reading that focuses on legal theory. Essentials of Pharmacy Law is written by a practicing pharmacist in clear, accessible, contemporary prose that concentrates on application. This user-friendly text is a compilation and commentary of selected federal laws and regulations

The Estrogen Elixir

The Estrogen Elixir
  • Author : Elizabeth Siegel Watkins
  • Publisher : JHU Press
  • Release : 16 April 2007
GET THIS BOOKThe Estrogen Elixir

In the first complete history of hormone replacement therapy (HRT), Elizabeth Siegel Watkins illuminates the complex and changing relationship between the medical treatment of menopause and cultural conceptions of aging. Describing the development, spread, and shifting role of HRT in America from the early twentieth century to the present, Watkins explores how the interplay between science and society shaped the dissemination and reception of HRT and how the medicalization—and subsequent efforts toward the demedicalization—of menopause and aging affected

Oncology Clinical Trials

Oncology Clinical Trials
  • Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
  • Publisher : Demos Medical Publishing
  • Release : 22 December 2009
GET THIS BOOKOncology Clinical Trials

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial

FDA in the Twenty-First Century

FDA in the Twenty-First Century
  • Author : Holly Fernandez Lynch,I. Glenn Cohen
  • Publisher : Columbia University Press
  • Release : 08 September 2015
GET THIS BOOKFDA in the Twenty-First Century

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
  • Author : Anonim
  • Publisher : John Wiley & Sons
  • Release : 19 September 2013
GET THIS BOOKBiotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Generic Drug Product Development

Generic Drug Product Development
  • Author : Leon Shargel,Isadore Kanfer
  • Publisher : CRC Press
  • Release : 24 October 2013
GET THIS BOOKGeneric Drug Product Development

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

Drug Discovery and Development - E-Book

Drug Discovery and Development - E-Book
  • Author : Raymond G Hill
  • Publisher : Elsevier Health Sciences
  • Release : 20 July 2012
GET THIS BOOKDrug Discovery and Development - E-Book

The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries’ trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories