ICH Postmarket Safety RWE Study Guidance Includes Focus On Data Considerations, Redesigns Conceptual Framework For Study Design Process

12-Digit NDC Rule Finalized By FDA; Manufacturers Have Seven Years Before Effective Date, With Three-Year Transition Before Enforcement

Prevision Policy Clips | A Test For “Plausible Mechanism” Pathway? Prime Medicine “Working Towards Final Alignment” With FDA On BLA Submission For PM359

FDA Deadline Tracker: First “Real” CNPV Reviews Deliver Split Outcomes; Faster Decisions Are Mixed Blessing At Best – And Come With Political Overtones

Streamlining Post-Approval Changes For NDA/ANDAs: FDA Seeks Input On Updates To “SUPAC” Guidances

Prevision Policy Clips | CMS Extends GENEROUS Model Application Deadline For Manufacturers

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”