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Article 30 Oct 2023 Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products United States Healthcare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Article 21 Sep 2023 A Step Forward: FDA Issues Three Draft Guidance Documents As Part Of Efforts To Modernize The 510(k) Notification Pathway United States Healthcare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
Article 25 Jan 2021 Medicare Expands Coverage Of "Breakthrough" Medical Devices And Codifies "Reasonable And Necessary" Standard United States Healthcare
Article 05 Nov 2020 New HHS Advisory Opinions Support Broad Application Of PREP Act Immunity For COVID-19 Response United States Healthcare
Article 26 Aug 2020 HHS Prohibits FDA From Requiring Premarket Review Of LDTs, Including During The COVID-19 Emergency United States Coronavirus
Article 24 Jul 2020 Podcast: Non-binding Guidance: FDA Regulation Of COVID-19 Diagnostic Tests And "Return To Work" United States Coronavirus
Article 10 Jul 2020 Analysis: FDA Response To COVID-19: A Shifting Landscape United States Coronavirus
Article 21 Nov 2019 A New Dawn For Challenges To FDA Actions? Kisor And The Tenuous Vitality Of Administrative Deference United States Healthcare
Article 23 Sep 2019 Podcast: Non-binding Guidance: Breakthrough Devices Program United States Healthcare
Article 10 Sep 2019 Podcast: Non-binding Guidance: Expedited Review Programs For Drugs And Biologics United States Healthcare