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.

Review:

I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents. -DENNIS CROUCH, Associate Professor of Law, University of Missouri School of Law, Editor of Patently-O.com An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from managers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business. -STEPHEN R. ALBAINY-JENEI, Attorney at Law, Editor of PatentBaristas.com

"About this title" may belong to another edition of this title.

Store Description

We offer a wide variety of books including fiction and non-fiction titles.

Visit Seller's Storefront

Seller's business information

SBYB, Inc.
900 Knell Rd, Montgomery, IL, 60538, U.S.A.

Terms of Sale:

We guarantee the condition of every book as it's described on the Abebooks web sites. If you're dissatisfied with your purchase (Incorrect Book/Not as Described/Damaged) or if the order hasn't arrived, you're eligible for a refund within 30 days of the estimated delivery date. If you've changed your mind about a book that you've ordered, please use the Ask bookseller a question link to contact us and we'll respond within 2 business days.

Shipping Terms:

Shipping costs are based on books weighing 2.2 LB, or 1 KG. If your book order is heavy or oversized, we may contact you to let you know extra shipping is required.

Payment Methods
accepted by seller

Add to Wants

Items related to The Generic Challenge: Understanding Patents, FDA and...

The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)

Voet, Martin A

Used - Soft cover

Seller's business information