Books > Professional & Technical > Biochemical engineering > Biotechnology
|
Buy Now
FDA's Drug Review Process and the Package Label - Strategies for Writing Successful FDA Submissions (Paperback)
Loot Price: R3,236
Discovery Miles 32 360
You Save: R237
(7%)
|
|
FDA's Drug Review Process and the Package Label - Strategies for Writing Successful FDA Submissions (Paperback)
Expected to ship within 12 - 17 working days
|
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.
General
Is the information for this product incomplete, wrong or inappropriate?
Let us know about it.
Does this product have an incorrect or missing image?
Send us a new image.
Is this product missing categories?
Add more categories.
Review This Product
No reviews yet - be the first to create one!
|
You might also like..
|
Email address subscribed successfully.
A activation email has been sent to you.
Please click the link in that email to activate your subscription.