The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.Hugh B. Wellons, Eileen Smith Ewing. Manual of Policy and Procedures (MaPP) 6010.5, aNDAs: Filing Review Issuesa (May 2003) http://www.fda.gov/cder/mapp/ 6010.5.pdf Manual of Policy and Procedures, MaPP 6020.3, aPriority Reviewanbsp;...
|Title||:||Biotechnology and the Law|
|Author||:||Hugh B. Wellons, Eileen Smith Ewing|
|Publisher||:||American Bar Association - 2007|