Life Sciences: Regulatory Information

This article focuses on key areas of life sciences including pharmaceuticals, medical devices, and biotechnology.

Sources cover all three areas:

• PLI plus - Practicing Law Institute's treaties, course handbooks, legal forms, program transcripts and answer books. Tip: may use the search function to have a jump start.

• Nexis Uni – IP cases, case law, government document.  

• FDA Regulatory Information portal 

• Emergo -- Web site of regulatory consulting firm provides regulatory updates in the areas of MedTech, Health Tech, and Pharmaceuticals / Biotech

• Endpoints News – Reports on global biotech, biopharma, drug, and health news and includes FDA+ channel.

Additional sources cover specific areas:

Biotech

• ABA’s Biotechnology and the Law - written for practicing lawyers, is designed to help identify the legal issues and processes that must be faced in building, marketing, and protecting a biotech business.  

• For more e/books on the topic, search HOLLIS Catalog - this link leads you to a quick search result. you may modify the search terms or use the filters under "Refine my results" to obtain different results.

Medical Devices

• Medical Devices Law and Regulation Answer Book

• FDA: Medical Devices portal 

• European Commission: Medical Devices Sector 

• Medical Device Regulatory Process Charts and Approval Timelines 

Pharmaceuticals

• Pharmaceutical Patent Law

• European Medicines Agency

• FDA: Drugs portal 

• International Society for Pharmaceutical Engineering - articles, guides, newsletter, etc.