Deadline Tracker: FDA’s Scorching August Brings 10 Novel Approvals, Including High Profile Reversals And A Pancreatic Cancer Breakthrough; September Could Be Busy Too

Quantitative Medicine Center Is Key Priority For CDER’s Davis; Biomarkers Consortium May Serve As A Model For Proposed QM “Innovation Network”

Hepatic Impairment Guidance Updated After Two Decades; PK Studies Should Include Full Range Of HI Subjects But FDA Says Severe-Only Participants Could Be “Reasonable Approach” In Some Cases

Prevision Policy Clips | Former FDA Chief Counsel And Legal Architect Of Modern FDA Peter Barton Hutt Passes Away

FDA Cautions Sponsors About International Trial Data – But Makes Clear It Will Still Accept It If GCPs Are Followed; Agency Promises To Beef Up International BIMO Inspections

Prevision Policy Clips | Preelection Government Shutdown Avoided, OMB Grant Rule Delay Part Of House-Passed Continuing Resolution

Common Deficiencies In Digital Health Technology Submissions: FDA Cites Algorithm Validation, Lack Of Patient-Centric Justification For Trial Endpoints

Prevision Policy Clips | MFN White House Deals Feature Nine Companies, Plus One In Stealth Mode

Prevision Policy Clips | MFN Pricing Deals: Takeda, Bayer, CSL Are Among Next Tier Of Companies

The State Of Digital Health Technologies At FDA: Sensor-Based DHTs Are Growing Field, Future Plans Will Be Informed By RFI

Nonhealing Chronic Wounds PFDD: CDER/CBER Ride Along For CDRH-Led Patient Input Meeting; Reclassification To Syndrome May Spur Therapeutic Development

Model-Integrated Evidence In Generic Drug Development: FDA Has Been Taking Lead On Modeling, But Time Is Right For Sponsors To Do More, Agency Officials Suggest

Prevision Policy Clips | FDA Deputy Chief Of Staff Is Stephen Mason; Former Amgen Exec Returns To Agency

Prevision Policy Clips | MFN Tier Two: “Most Favored Nation” Pricing Deals Expected To Be Announced Aug. 31

Advisory Committee Tracker: The Meeting Void Continues Amid Leadership Transition

Prevision Policy Clips | Deputy Commissioner For Drugs? Latest FDA Leadership Plan Under Overton

FDA Leadership Uncertainty Remains After Overton Announcement; Acting Center Directors, Deputy Commissioner Vacancy Leave Many Open Questions

Prevision Policy Clips | Capricor DMD Drug Headed For Approval? Deramiocel Gets New Nov. 22 PDUFA Date For “Refined” Indication

Prevision Policy Clips | FDA Net Staffing Loss Under Trump Tops 4,600

Digitally Derived Measures White Paper Is CDER/CBER/CDRH/OCE Look At Key Factors To Use DDMs In Clinical Investigations; Evidence Generation Should Be “Commensurate with Intended Use”

Prevision Policy Clips | “Digitally Derived Measures” For Use In Clinical Trials: FDA White Paper

Cell/Gene Therapy FAQs: FDA’s Final Guidance Shortens Pre-BLA Meeting Time With Sponsors, Encourages Earlier Requests For Rolling Review

Active Immunotherapy Potency Draft Guidance Released By FDA To “Supplement” 2023 Advice For Cell And Gene Therapies; “Challenges” Are Different For ACTIMPs

Prevision Policy Clips | FDA Nominee Overton Is “A ROCKSTAR,” Trump Affirms, But Cassidy Has Doubts

FDA Proposes “Competency-Based” Premarket Evaluation Of GenAI-Enabled Devices, Range Of Postmarket Options; Public Feedback Is Main Goal