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

Prevision Policy Clips | HHS Expands Coverage Of Opioid Use Disorder Therapies

FDA Deadline Tracker: First Novel CNPV Approvals Coming In February? Warning Signs Abound For Other Applications

Advisory Committee Tracker: Still No Drug Panels Planned For 2026; “RISE” Meetings Are One Area Where FDA Public Engagement Continues

Prevision Policy Clips | FDA Pediatric Voucher Renewal, PBM Reforms On Cusp Of Enactment

Prevision Policy Clips | “Clear Labels Act” Would Require Country Of Origin Labeling For Pharmaceuticals

Achieve Smoking Cessation Treatment Cytisinicline Has FDA CNPV, But ICER Committee Sees Little Benefit Versus Chantix; Price Below $3,000 Per Year Could Be Cost Effective

Sanguine Sign At CBER: Grifols’ Blood Product Fesilty Approval Demonstrates Steady, On-Time Reviews Despite Upheaval In Center Management

Prevision Policy Clips | FDA Rare Disease Hub March 30 “RISE” Meeting Will Focus On Data Sharing

TrumpRx Ready For Takeoff? HHS OIG Tentatively Clears Runway For DTC Drug Sales Via New Advisory Opinion; RFI Suggests Many Unanswered Questions