Article
22 Dec 2025
Biosecure Act Positioned For Vote In U.S. Senate
AUTHORS CONTENT
Article
24 Oct 2025
Replay: Wearables Webinar Series, Part 1: Update On FDA Regulation On Wearables (Video)
Article
26 Aug 2025
FDA Issues Notice Of Intent To Rescind Rule Extending Authority To Laboratory Developed Tests
Article
29 Jul 2025
FDA Issues Warning Letter Classifying Wearable Blood Pressure Monitor As A Device
Article
11 Jun 2025
Take Care When Paying Volume-Based Compensation To Sales Agents To Avoid Anti-Kickback Statute Violations
Article
28 Feb 2025
First Circuit Embraces More Restrictive View Of False Claims Act Kickback Enforcement Provision
Article
27 Feb 2025
Court Extends TROs Enjoining Enforcement Of NIH Rate Change Within 22 Plaintiff States
Article
27 Feb 2025
Federal Court Enjoins Enforcement Of NIH'S Rate Change Notice Regarding Indirect Costs
Article
11 Feb 2025
FDA Revokes Red Dye No. 3 Authorization For Food, Drinks And Drugs - What Manufacturers Need To Know
Article
07 Feb 2025
FDA Finalizes Guidance On Communicating Scientific Information About Unapproved Uses Of Medical Products
Article
04 Feb 2025
FDA Issues Draft Guidance Q&A On Developing Potential Cellular And Gene Therapy Products
Article
31 Jan 2025
Federal Circuit Affirms Delisting Patents Claiming Device Components Of Drug Product Without Active Ingredient
Article
29 Jan 2025
Federal Circuit Affirms Delisting Patents Claiming Device Components Of Drug Product Without Active Ingredient
Article
23 Oct 2024
FDA Issues Guidance On Remote Clinical Trial Activities
Article
25 Sep 2024
FDA Issues Draft Guidance On Predetermined Change Control Plans For Medical Devices
Article
24 Sep 2024
FDA's Latest Draft Guidance On Medical Device PCCPs Incorporates FD&C Act Changes
Article
16 Jul 2024
Federal Circuit Revives Induced Infringement Suit Against Generic Pharma When Its Skinny Label Is Skinny Enough
Article
24 May 2024
FDA Finalizes New Rule For Lab-Developed Tests
Article
22 May 2024
FDA's New Rule Regulates Lab-Developed Tests Under FD&C Act
Article
23 Feb 2024
FTC Supports Marching In On Patent Rights As A Mechanism To Control Drug Prices