Kellie Combs

FDA Issues Draft Guidance Describing When A Confirmatory Trial Of A Drug Seeking Accelerated Approval Is "Underway"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

Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance On Requirements And Processes For Accelerated Approval

Non-Binding Guidance: How Drug And Device Companies Can Tackle Internet Misinformation (Podcast)

Non-Binding Guidance: Preview Of The Second Annual Ropes & Gray Rare Disease Forum (Podcast)

U.S. Life Sciences Regulatory And Compliance Outlook 2024 (Part II): Product Development And Pricing (Podcast)

First Circuit Affirms Convictions Of Former Acclarent Executives Related To Off-Label Promotion Of Medical Device

Non-Binding Guidance: FDA's Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products (Podcast)

Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products

Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning