RWE Use Cases Published By FDA; One Novel 2025 Approval Relied On Real-World Evidence For Efficacy Support

Prevision Policy Clips | ANDA Approval Letters Will Be Streamlined: New FDA Guidance

ANDA Sponsor Post-Approval Obligations: New FDA Guidance Summarizes Policies And Resources As Part Of Effort To Streamline Approval Letters

Lessons Learned From CNPV Reviews: Three Sponsors Give Feedback During FDA Hearing; Enhanced Engagement Is Most Valuable, Role Of Commissioner’s Office Less Clear

FDA Stays Poker-Faced On CNPV Program During “Part 15” Hearing; Supporters, Critics Both Call For Clearer Eligibility Criteria

US/China Biopharma Deals Draw Legislative Response: BINSA Would Require US Treasury Review Of Future Agreements; HHS Would Help Define Scope Of Oversight

Prevision Policy Clips | FDA Stays Poker-Faced On CNPV Program During “Part 15” Hearing

AI’s Role In Regeneron Otarmeni Review Discussed At CBER Town Hall; CNPV Model Led to Quick Review, With AI in Supporting Role

Prevision Policy Clips | CNPV Feedback Meeting: FDA Team Will Be Led By Deputy CMO Mundkur

Do Longevity Drugs Need A Separate FDA Path? THRIVE Act Is One Option; Sponsors At Reagan-Udall Event Focused More On FDA Guidance Than Legislative Change

Prevision Policy Clips | Oz At The White House: “It’s Going To Be Difficult For Pharmaceutical Companies To Pull Back”

FDA Updates Payor Communication Guidance To Reflect Statutory Change; Substance Of 2018 Advice Unchanged

FDA Deadline Tracker: Eight NMEs Clear Agency In May, And June Could Be Just As Busy; AZ Camizestrant Gets A Three-Month Reprieve

FDA Gene Editing “Leveraging” Draft Guidance Provides Menu Of Options For Sponsors To Build On Prior Knowledge; Principles “May” Apply More Broadly To Other CGTs, FDA Says

Prevision Policy Clips | FDA Gene Editing “Leveraging Knowledge” Draft Guidance Released For Comment

Another Normal VRBPAC, But Neither FDA Nor Committee Sees COVID Strain Selection As “Routine”; Agency Open To Changing Timeline For Selections, But Warns Of “Tradeoffs”

BSUFA IV Negotiations Making Progress: Combination Product Enhancements Are Key Industry Ask In Current Round; “America First” Provisions Will Carry Over From PDUFA

Prevision Policy Clips | May Mixers: FDA Acting Commissioner Diamantas Meets With Key Lawmakers, Trade Groups

Checkpoint Inhibitors, CD3s Do Not Need Three-Month Animal Tox Studies, FDA Says In Draft Guidance On Oncology Biologics

Prevision Policy Clips | Another Normal VRBPAC: Committee Backs FDA COVID-19 Vaccine Strain Update

Anti-Aging Claims and FDA: “Intrinsic Capacity” May Have Potential As An Endpoint, FDAers Suggest, But Progress Likely Begins With Studies Of Mortality, Disease Prevention

Prevision Policy Clips | Single-Trial Policy In Action? Outlook Will Resubmit Ophthalmic Bevacizumab BLA

Prevision Policy Clips | PDUFA VIII Agreement Is Set, Next Steps Outlined

Advisory Committee Tracker: Moderna Flu Vaccine Set For June Review, Sanofi Tzield CNPV Indication Meeting In The Works; Adjudicating The Makary Era?

FDA Considers Broadening NMIBC Bladder Cancer Drug Use Beyond Patients With CIS; Agency Continues To Encourage Drug Development In Period of BCG Shortage