Article
28 Jan 2025
2024 FDA Enforcement Review: Quality And Transparency Remain Critical Concerns
AUTHORS CONTENT
Article
27 Jan 2025
FDA Issues Draft Guidance Describing When A Confirmatory Trial Of A Drug Seeking Accelerated Approval Is "Underway"
Article
16 Jan 2025
FDA Finalizes Guidance On Communication Of Scientific Information On Unapproved Uses And Releases Updated First Amendment Analysis
Article
14 Jan 2025
One Size Does Not Fit All: EU, UK, And U.S. Regulatory Developments In The Age Of Precision Medicine
Article
09 Jan 2025
Clinical Trial Protocol Deviations: A New FDA Draft Guidance To Ring In The New Year
Article
17 Dec 2024
FDA Finalizes Guidance On Predetermined Change Control Plans For AI-Enabled Medical Device Software
Article
11 Dec 2024
Stem Cell Litigation Update: FDA Won The Latest Battle, But The Future Of HCT/P Enforcement Remains Unclear
Article
20 Nov 2024
Controlling Opinions: Navigating DEA Diversion Investigations (Podcast)
Article
30 Sep 2024
Three Of A Kind: FDA Guidance Documents Provide Recommendations On Non-Traditional Clinical Trial Designs
Article
11 Sep 2024
FDA "PreCheck"? FDA Issues Draft Guidance On Predetermined Change Control Plans For Medical Devices
Article
02 Aug 2024
Non-Binding Guidance: How Drug And Device Companies Can Tackle Internet Misinformation (Podcast)
Article
30 Jul 2024
Controlling Opinions: Latest Developments Regarding Controlled Substance Issues In Telemedicine (Podcast)
Article
03 Jul 2024
Mifepristone Litigation Update: Supreme Court Ruling On Standing Grounds Preserves The Status Quo Of FDA Regulation Of Mifepristone
Article
11 Jun 2024
Medical Device Enforcement Update: Two Recent Settlements Pack A Punch
Article
11 Mar 2024
Non-Binding Guidance: Preview Of The Second Annual Ropes & Gray Rare Disease Forum (Podcast)
Article
20 Feb 2024
Top 10 Takeaways From FDA's Revised Quality System Requirements For Medical Devices
Article
23 Jan 2024
U.S. Life Sciences Regulatory And Compliance Outlook 2024 (Part I): FDA Enforcement And Litigation (Podcast)
Article
02 Jan 2024
First Circuit Affirms Convictions Of Former Acclarent Executives Related To Off-Label Promotion Of Medical Device
Article
23 Nov 2023
Controlling Opinions: Introducing Ropes & Gray's Controlled Substances Compliance Update (Podcast)
Article
21 Nov 2023
Non-Binding Guidance: FDA's Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products (Podcast)