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

FDA Eager To Encourage More Neonatal Drug Development, But Will Message Of “Flexibility” Be Lost In The Headlines? Agency Officials Acknowledge Need To Ensure That Early Advice Is “Helpful”

Prevision Policy Clips | White House Tightens Control Over Kennedy? FDA Deputy For Policy Grace Graham Is HHS Senior Counselor For FDA-Related Issues

340B Providers Expect Medicare Payment Cuts In 2027; HRSA Seems Ready To Renew Push For Rebate Model In 340B; MFP Implementation Causing Headaches

“Stable” FDA Is Key Theme At House Drug Pricing Hearing After Moderna RTF, Political Pressure May Ramp Up On Makary/Prasad; MFN Details Are Area Of Bipartisan Interest

Prevision Policy Clips | CMS Town Hall Discussion Of 2028 Drug Price Negotiation Class Scheduled For April 22-23

Prevision Policy Clips | Moderna Receives RTF For mRNA Flu Vaccine, FDA Says Control Arm Is Not “Best-Available Standard Of Care” In US

Prevision Policy Clips | FDA Division of Hepatology and Nutrition Changes: Acting Associate Director Gerri Baer Departs FDA

FDA’s Loss Of Expertise Will Force Industry To Lead On Issues Like Biomarkers, Woodcock Says; Is Political Firewall Breeched Or Is It A “Special Time” At FDA?

FDA Submission “Pizza Tracker” Coming Soon, eCTD 4.0 Has Bumps But Agency Outlines Key Benefits; “Elsa” Uptake Accelerating With Agentic AI Up Next

Prevision Policy Clips | FDA Warns GLP-1 Compounders To Expect “Decisive Steps”; Hims & Hers Backs Down

“Bite-Sized” AI Bills Could Ride-Along With PDUFA Reauthorization, Former Staffer Predicts; Ex-FDAer Fakhouri Worried About “Death By Pilots” In AI Field

FDA Biomarker Qualification Improvements Should Be Addressed In PDUFA VIII, Rep. Degette Affirms; Will Proprietary Pathway Re-Emerge?

Prevision Policy Clips | PDUFA VIII Should Fund Biomarker Qualification At FDA, Rep. DeGette Says

Prevision Policy Clips | Prescription Drug Supply Chain And “Root Drivers” Of Rx Costs Will Be Focus Of House Hearing February 11

“America First” User Fees Are Tough Sell: Industry Pushes Back On FDA Proposals To Incentivize Domestic Manufacturing In GDUFA IV Negotiations

“De-Linking” By Decree: FTC/Express Scripts Settlement Requires PBM To Offer Rebate-Free Option To Plans; TrumpRx Sales Would Count Towards Deductible

Prevision Policy Clips | Amgen Defends Tavneos (Avacopan) After FDA Requests Withdrawal

FDA Rare Disease Hub Gains Traction With $1 Million Budget For 2026; Agenda Includes PFDD Workshop And Plan For Rare Disease Staff Training