“Three-Year Exclusivity” Guidance Details FDA’s Thinking Behind Hatch/Waxman Supplemental Exclusivity Decisions; Separate Cohorts In Same Trial Can Qualify For Separate Exclusivity, FDA Says

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