Joshua Oyster

2024 FDA Enforcement Review: Quality And Transparency Remain Critical Concerns

FDA Issues Draft Guidance Describing When A Confirmatory Trial Of A Drug Seeking Accelerated Approval Is "Underway"

FDA Finalizes Guidance On Communication Of Scientific Information On Unapproved Uses And Releases Updated First Amendment Analysis

One Size Does Not Fit All: EU, UK, And U.S. Regulatory Developments In The Age Of Precision Medicine

Clinical Trial Protocol Deviations: A New FDA Draft Guidance To Ring In The New Year

FDA Finalizes Guidance On Predetermined Change Control Plans For AI-Enabled Medical Device Software

Stem Cell Litigation Update: FDA Won The Latest Battle, But The Future Of HCT/P Enforcement Remains Unclear

Controlling Opinions: Navigating DEA Diversion Investigations (Podcast)

Three Of A Kind: FDA Guidance Documents Provide Recommendations On Non-Traditional Clinical Trial Designs

FDA "PreCheck"? FDA Issues Draft Guidance On Predetermined Change Control Plans For Medical Devices