Article 08 Aug 2025 Implications Of FDA's "Radical Transparency" Plan For Complete Response Letters United States Healthcare
Article 29 Jul 2025 FDA Begins To Accept Nominations For The Commissioner's National Priority Voucher Pilot Program United States Healthcare
Article 14 Jul 2025 "False Claims Act Working Group" Signals Aggressive FCA Enforcement In Health Care And Life Sciences United States Healthcare
Article 23 Jun 2025 FDA Announces Commissioner's National Priority Vouchers To Facilitate Expedited Access To Certain Drugs United States Healthcare
Article 02 Jun 2025 AI, Medical Products & FDA, Part 3: AI In Drug & Device Commercialization (Podcast) United States Healthcare
Article 04 Apr 2025 LDTs Are Not Devices Under The FDCA: Eastern District Of Texas Vacates FDA Final Rule On LDTs United States Healthcare
Article 13 Feb 2025 "DOGE" Reportedly Accesses CMS Contracting And Payment Systems United States Healthcare
Article 16 Jan 2025 FDA Finalizes Its SIUU Guidance: An Analysis Of The Key Changes From The 2023 Draft Guidance United States Healthcare
Article 27 Dec 2024 Recent SEC Case Against Biotech Company Highlights The Intersection Between FDA Findings And SEC Enforcement United States Commercial
Article 17 Dec 2024 FDA Issues New Draft Guidance For Expedited Program For Serious Conditions — Accelerated Approval Of Drugs And Biologics United States Healthcare
Article 10 Dec 2024 FDA LDT Final Rule Litigation — Status And What May Happen Next United States Healthcare
Article 09 Dec 2024 LDT Final Rule Litigation — Status Of Pending Court Challenges And What May Happen Next United States Healthcare
Article 15 Jul 2024 FDA Issues Revised Draft Guidance On Addressing Misinformation About Medical Devices And Prescription Drugs United States Healthcare
Article 03 Jul 2024 Chevron Overturned: What Does It Mean For Life Sciences Companies? United States Healthcare
Article 21 May 2024 FDA LDT Rule Raises Question Of Whether FDA Should Regulate Diagnostic Testing United States Healthcare
Article 20 May 2024 What You Should Know About The FDA's New Final Rule On LDTs United States Healthcare
Article 14 May 2024 What You Need To Know About The FDA Laboratory Developed Test Final Rule United States Healthcare
Article 13 May 2024 FDA Intends To Regulate Many Clinical Labs As Medical Device Manufacturers: What You Need To Know About The Laboratory Developed Test Final Rule United States Healthcare
Article 08 May 2024 Five Key Takeaways From FDA's Updated Draft Guidance On Biosimilars Promotion United States Healthcare
Article 14 Mar 2024 EXPERT INSIGHTS—FDA Started A Process To 'Downclassify' Most High-Risk IVD Types: Here Is Why, (Mar 5, 2024) United States Healthcare