Prevision Policy Clips | Who Fired Hoeg? Former CDER Director Suggests The Pharmaceutical Industry

Accelerated Approval For Biomarkers? FOCR Working Group Proposes Tiered Approach “With Clearer Interim Signals” As Part of Revised Biomarker Qualification Pathway

Prevision Policy Clips | User Fee Reauthorization “Particularly Important” Due to FDA Staffing Cuts, Political Dynamics, Sen. Kaine

Lessons In Quality Management Maturity: Preventive, Risk-Based Maintenance Ensures Operational Reliability, FDA Says

Prevision Policy Clips | Real World Evidence For Generics? FDA’s Lionberger Suggests “There Are Opportunities”

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FDA Gene Editing “Leveraging” Draft Guidance Provides Menu Of Options For Sponsors To Build On Prior Knowledge; Principles “May” Apply More Broadly To Other CGTs, FDA Says

Prevision Policy Clips | FDA Gene Editing “Leveraging Knowledge” Draft Guidance Released For Comment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