Clinical Support Software Can Get Specific, FDA Says In Updated Guidance; Change Could Mean More Explicit Rx Recommendations; Wearables Also More Broadly De-Regulated

GDUFA IV Update: Inspections Are Key Early Theme; Industry Requests Include Review Tracking Portal, Improving ANDA Timeline Predictability

Prevision Policy Clips | FDA Broadens Regulatory Exemptions For Wearables, Some Clinical Decision Support Software

Advisory Committee Tracker: Dry January For FDA Advisory Committees; Few Opportunities To Hear Direct From Career Staff

Prevision Policy Clips | CDC Downgrades Flu, Rotavirus, Hepatitis A/B And Meningococcal Vaccines

PDUFA VIII Update: FDA Proposes No New Resources For Cell & Gene Therapies; Industry Proposes Bigger RWE Push, First-Cycle Review Changes

FDA Deadline Tracker: FDA Delivers Strong Approval Numbers For 2025, But Warning Signs Are Growing Heading Into 2026; Does “On-Time” Mean More CRLs?

Prevision Policy Clips | FDA GI Division Director Will Be Matthew Kowalik

The GLOBE List: 62 Products Identified By CMS As Potentially Subject To Reference Pricing Under New Model; Three-Quarters Are From Firms With White House Deals

Prevision Policy Clips | CDER Ends 2025 With 48 NME Approvals

Prevision Policy Clips | Where Are The CNPV Approvals?

CMS GLP-1 Demo Will Kickstart Part D Coverage For Weight Loss In July; Plan Will “BALANCE” Drug Access With Lifestyle Support; Will PDPs Sign On?

Prevision Policy Clips | 340B Rebate Pilot Program On Hold After Federal Court Ruling

Medicare MFN Pricing Rules Unveiled: “GLOBE” And “GUARD” Would Turn Inflation Rebates Into Reference Pricing Tool; Impact Unclear In Light Of White House Deals

Prevision Policy Clips | CMS International Reference Pricing Rules Unveiled: “GLOBE” (Part B) And “GUARD” (Part D)

MFN Pledges Are Now Industry-Wide Standard: All 17 Firms Targeted By Trump Have Reached Agreements; Trump Sounds Ready To Turn The Page

Prevision Policy Clips | MFN Pricing Deals Delay Apparent Plan To Overhaul Vaccine Schedule

BIOSECURE Set To Become Law: OMB Will Take Lead On Listing Biotechs “Of Concern” But It Could Be 2029 Before Prohibitions Take Effect

Prevision Policy Clips | Angelo de Claro Named Oncology Center Of Excellence Acting Director

OTC Epipen? FDA Open To Switching Epinephrine For Anaphylaxis; Naloxone May Be One Model, ACNU Could Help; New Rx Formulations Also Encouraged

Prevision Policy Clips | CDC Adopts New Hepatitis B Vaccine Birth-Dose Recommendation

Prevision Policy Clips | De-Identified Data Can Be Included In RWE Submissions, FDA Declares; Applies Only To Devices At First

Diversity Action Plan References Deleted From Updated Guidances Posted By FDA; 2020 Trial Diversity Guidance No Longer References “Diversity,” But Advice Remains The Same

Prevision Policy Clips | FDA Finalizes Safety Reporting Guidances For Sponsors And Clinical Investigators

Prevision Policy Clips | PDUFA VIII Negotiations: FDA Proposes To Limit Small Business Waiver To US-Based Applicants, Rare Disease Hub To Take On More