Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
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- Synopsis
- This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
- Copyright:
- 2016
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9781627346252
- Related ISBNs:
- 9781627346177
- Publisher:
- Brown Walker Press (FL)
- Date of Addition:
- 08/20/19
- Copyrighted By:
- Martin A. Voet
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Law, Legal Issues and Ethics, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.
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- by Martin a. Voet
- in Nonfiction
- in Law, Legal Issues and Ethics
- in Medicine