Article 07 Nov 2023 Lessons From The Pandemic: FDA Proposes Permanently Adopting Alternative Tools For Drug Facility Inspections United States Healthcare
Article 01 Nov 2023 Non-binding Guidance: FDA's Proposed Rule On Laboratory Developed Tests (Podcast) United States Healthcare
Article 30 Oct 2023 Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products United States Healthcare
Article 04 Oct 2023 Regulation Without Legislation: FDA Proposes Rule To Regulate Laboratory Developed Tests And End Historical Enforcement Discretion Policy United States Healthcare
Article 21 Sep 2023 A Step Forward: FDA Issues Three Draft Guidance Documents As Part Of Efforts To Modernize The 510(k) Notification Pathway United States Healthcare
Article 29 Aug 2023 FDA Finalizes Guidance On Informed Consent For Clinical Investigations United States Healthcare
Article 19 Jul 2023 Non-binding Guidance: Introducing The U.S. Medical Device Recalls Resource Manual (Podcast) United States Healthcare
Article 08 Dec 2021 HHS Reverses Course On LDTs: COVID-19 LDTs Again Require FDA Premarket Review United States Healthcare
Article 29 Nov 2021 CMS Finalizes Repeal Of Medicare "Breakthrough" Device Coverage Rule, Pledges To Invite Further Industry Input United States Healthcare
Article 07 Mar 2021 Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning United States Healthcare