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

NTAP Class Of 2027: Nine Drugs Apply For Enhanced Medicare Payment For FY 2027; Seven are Orphan Drugs, Five Are Regenerative Meds; Bristol Makes Second Attempt For Cobenfy

Testosterone Label Expansion Will Need “Strong Scientific Justification,” CDER’s Davis Says; Comments Temper Enthusiasm From FDA’s Hand-Picked Panel

Prevision Policy Clips | BIOSECURE Provisions Head To Senate

PDUFA VIII User Fee Talks: FDA Steering Committee Has Small Handful Of Experienced Negotiators; Most Previous Participants Were RIFed Or Retired

CNPV Proof Of Principle? USAntibiotics Augmentin XR Re-Approval Still Leaves Many Unanswered Questions About New FDA Pathway

New Approach Methodologies In Pediatrics: First Step Is Following ICH Guidance, FDA Officials Say; Tools To Support Pediatric Safety Extrapolation Already Exist