PDUFA VIII Meeting Reinforces “America First” Theme; FDA Commits To “Maintain And Restaff Expertise” For Cell & Gene Therapy Reviews

CDER CRLs Have Been Trending Down Over Time, FDA Report Says, Though Novel BLAs Are An Outlier; Report Intended To Rebut Headlines About 2025 Rejections

Expedited IND Pilot Launches With 8-10 Candidates For Rolling Review To Be Selected By Mid-December; “Novel” Therapies, US-Based Trials To Be Prioritized

Prevision Policy Clips | Expedited IND Pilot Launches: FDA Sets October 30 Deadline For Applications

CMMI Cell And Gene Therapy Model Is Bipartisan Drug Pricing Success, CMS Advisor Says; Expanding Model Will Involve Finding Right Therapeutic Context

REMS For Therapeutic Psychedelics: Stakeholders Share Variety Of Opinions On Safety Requirements During Part 15 Hearing; Targeted Approach Urged

Prevision Policy Clips | CNPV Future Will Be Up To Next FDA Commissioner, Deputy Graham Indicates

“CoGenT” Gene Therapy Global Pilot Future Is Uncertain, But Collaborative Review Remains Possible; Parallel Scientific Advice Program Has Little Uptake

Prevision Policy Clips | Psychedelic Drug Re-Dosing Questions Can Be Addressed In Post-Market Studies, FDA Clarifies

Prevision Policy Clips | Biotech Innovation And Biosecurity: House Science, Space And Technology/Oversight Subcommittee Hearing Sept. 16

Psychedelics, GLP-1s, Repurposed Drugs May Help Transform Pain And Substance Use Disorder Treatment Landscape, Speakers Suggest During FDA Opioid Feedback Meeting

Prevision Policy Clips | HHS Deputy Nominee Klomp Confirmation Hearings Set For September 15-16

FDA Drug Review Directors: Over 50% Turnover So Far In The Trump Administration; New Managers Have Significant Agency Experience – But How Deep Is The Bench?

FDA Leadership Changes Ahead Of Overton Emphasize Continuity – And Path Of Least Resistance; Davis, Mikhail Shed “Acting” Designations At CDER And CBER

Prevision Policy Clips | Leadership Stability At FDA? CDER, CBER Directors No Longer “Acting”

Reining In Part D: MedPAC Likely To Endorse Tweaks To Benefit Design In Light Of Surging Costs; Members Call For More Direct Action On Launch Pricing

Prevision Policy Clips | FDA Approves First ctDNA-Guided Therapy Despite Advisory Committee Rejection

The Part D Explosion: Medicare Outpatient Drug Spending Jumped 22% In 2025, MedPAC Staff Reports; Benefit Redesign, Growth In Cancer Therapies And GLP-1s Are Key Drivers

Prevision Policy Clips | FDA Seeks Input On Accelerating Botanical Product Development

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