Pharma Med Device
Ropes & Gray provides counsel, representation, and strategic advice to companies subject to FDA compliance and related international food and drug laws. Command of FDA regulatory matters and associated issues is critical in patent and antitrust law, when seeking product approvals, while developing lifecycle management strategies, and in assuring that products are marketed in compliance with federal, state and international requirements. Our lawyers have served in Congress and in the administrative agencies of the U.S. federal government; experience which informs the design and execution of solutions which address our clients’ concerns. For more on our FDA practice, please click here.
- FDA Issues Draft Guidance and Proposed Rule on the Nonproprietary Naming of Biological Products
(September 8, 2015)
- Cures Are on the House: House Passes 21st Century Cures Act, but Senate Awaits
(July 23, 2015)
- House Passes 21st Century Cures Act: What Does it Mean for Clinical Research?
(July 23, 2015)
- Progressing Toward a Cure: House Committee Unveils Revised, Streamlined 21st Century Cures Discussion Draft
(May 7, 2015)
- Orange Book Patent Listing and Patent Certifications: Key Provisions in FDA’s Proposed Regulations Implementing the Medicare Modernization Act of 2003
(February 18, 2015)
- FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT
(January 26, 2015)
- FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management
(October 3, 2014)