Prevision Policy Clips | FDA Considering Updates To Guidances On Scale Up & Postapproval Changes (SUPAC)

Gradually, Then Suddenly: FDA Makes Case Animal Testing Alternatives Are Ready For Faster Adoption; Sponsors Urge “Weight-Of-Evidence” Approach

FDA Food Allergy “Expert Panel”: Agency Staff See “Single Trial” Efficacy Standard As Easing R&D Burden For New Therapies

Prevision Policy Clips | The First “Real” CNPV Approval: BI Hernexeos Clears FDA

FDA Advisory Committee Restart Is Key Theme At Senate Hearing On Rare Diseases; Sen. Johnson In Contact With CDER’s Hoeg On Biohaven, Chair Scott Defends Makary

CDER Guidance Agenda Features New Items Focused On Advanced Manufacturing, Other CMC Issues; Revised Draft On Payor Communications Planned

Prevision Policy Clips | Surgeon General Nominee Casey Means Testifies That “Vaccines Save Lives” But Urges “Informed Consent”

Advisory Committee Tracker: Vaccine Committee Meeting Set For March; “Routine” Event Will Be Anything But Routine In Context Of Recent Vaccine News

Prevision Policy Clips | Mission Accomplished On Drug Pricing? State Of The Union Features Familiar Themes

AI In Regulatory Review: Current Use Cases Include FDA Oncology AI “Super-Users” Developing Prompts For Broader Adoption; AI-Related Submissions Reached About 500 In 2025

ctDNA Continues Slow Progress Towards Endpoint Status: Sponsors Urged To Include It In Trials To Help Build The Case – But May Be Wary Of Doing So

Prevision Policy Clips | FDA Direct Podcast Returns For Rare Disease Day After Three Month Hiatus

“Plausible Mechanism” Guidance Does Not Limit Patient Population Size; “Leveraging” Data Encouraged, But Not “Process Approvals”

Prevision Policy Clips | Rare Disease Regulatory Barriers Will Be Focus Of Senate Aging Committee Hearing

“America First” Proposals May Be Too Ambitious For PDUFA VIII As March Deadline Looms; FDA Says 400 New Hires Ready To Go

Prevision Policy Clips | FDA “Plausible Mechanism” Guidance Expected To Be Published Feb. 23

FDA “Single-Trial Standard” Declared In NEJM, But Sponsors Still Face Dilemma Without Evidence Of Buy-In From Staff; Higher Regulatory Bar In Disguise?

Prevision Policy Clips | Single-Trial Standard Is “Default” Setting For Drug Approvals, FDA Commissioner Makary Declares

Generic Industry Holds Ground On “America First” User Fees; “Better Incentives” For Domestic Manufacturing Lie “Outside Of User Fee Authority”

Cassidy’s Agenda For PDUFA VIII: “Least Burdensome Standard” Should Apply To NDAs, HELP Committee Report Argues; Seeks More “Judicious” Use Of Clinical Holds

Prevision Policy Clips | FDA About-Face On Moderna Flu Vaccine: Review Begins With Aug. 5, 2026 Goal Date

The Price Negotiation Template: CMS Releases Details On MFP Discussions For Class Of 2027; Looks Similar To First Round

Prevision Policy Clips | CNPV Review Meets Rising Bar For Accelerated Approval: Disc Medicine Receives Complete Response Letter

FDA Biomarker Qualification Lessons Learned: Data Acquisition Presents Challenges, Standardization Is Paramount; Workload Still An Issue

AI In Product Development: Biological Plausibility In AI Models Is “Highly Encouraged” But “Not Absolutely Required,” CDER AI Review Team Lead Says