Article 13 May 2024 FDA's Final LDT Rule Is Here, And The Changes Show The Agency Is Serious And Actually Listening To Stakeholders United States Healthcare
Article 08 Apr 2024 FDA Warning Letter Is A Stark Reminder That If You Claim Your Product Is RUO, It Has To Be RUO United States Healthcare
Article 15 Mar 2024 Health Law Diagnosed – A Discussion On The Regulatory Requirements For LDTs (Podcast) United States Healthcare
Article 14 Mar 2024 FDA Faces Critical Deadlines In 2024, Even Without An Election Looming United States Healthcare
Article 10 Jan 2024 White House Launches Initiative On Women's Health Research United States Healthcare
Article 09 Jan 2024 Looking Back And Moving Forward: MoCRA Regulatory Developments Ring In The New Year United States Healthcare
Article 14 Nov 2023 Connecticut Law Imposes New Requirements On Pharmaceutical Manufacturers, Defined To Include Device And Cosmetic Manufacturers, That Employ "Pharmaceutical Sales Representatives" United States Healthcare
Article 01 Nov 2023 Guidance From FDA Clarifies A Key Issue For Industry: Non-Promotional Presentations About Unapproved Uses Of Medical Products Can Be Produced By The Products' Sponsors Without Violating Off-Label Rules United States Healthcare
Article 03 Oct 2023 Five Topline Takeaways From FDA's Proposed Rulemaking On Lab-Developed Tests United States Healthcare