COVID Vaccines Moving To Flu Model: FDA Advisory Committee Will Be Asked To Ratify “Simplified” Annual Strain Selection Process

FDA Sticks To Orphan Drug Exclusivity By Indication, Despite Catalyst Ruling; Clarity For Now – But More Litigation Likely

Prevision Policy Clips | FDA Responds To Catalyst Ruling At Last: No Change In Orphan Drug Exclusivity Policy Going Forward

Cidara/Melinta’s Antifungal Rezafungin Likely To Have Limited Use Indication Only; Ad Comm Told That FDA Does Not Believe Broader Claim For Candidiasis Is Supported By Available Data

Prevision Policy Clips | Lilly’s Donanemab For Alzheimer’s Gets CRL For Accelerated Approval, But May Mean Little If Timeline Holds

Prevision Policy Clips | MPox Drug Development Draft Guidance Announced By FDA January 19

FDA Oncology Dose Optimization Guidance: Randomize Where Feasible, Breakthrough Status Does Not Obviate Obligation To Find Optimal Dose Pre-approval

Prevision Policy Clips | RSV Adult Vaccine Race Heats Up: Moderna To Submit BLA To FDA In The First Half Of This Year

IRA Impact On Small Molecule Development: MedPAC Member Argues That Part D Redesign, Proposed Part B Reforms May “Cancel Out” Price Negotiation Disincentives

The Part D Baseline: MedPAC Will Be Watching For Impact Of Plan Changes On Beneficiary Access And Choices During IRA Implementation Period

Prevision Policy Clips | FDA Dose Optimization Draft Guidance For Cancer Drugs Builds On OCE’s Project Optimus, Not For Gene And Cell Therapies

Prevision Policy Clips | CMS Opens National Coverage Review Of ViiV’s Apretude For PrEP

FDA Gets Granular On Dose Labeling: New Guidance On “Dosage & Administration Section” Dramatically Expands Advice And Examples From 2010 Predecessor

Medicare Price Negotiation Implementation Timeline Unveiled By CMS: “Small Biotech” Exception Is First Action Item, Overall Guidance Due By Summer

Prevision Policy Clips | FDA Updating Guidance On “Dosage & Administration” Section Of Labeling

Regeneron Eylea Pediatric Use Labeling Review: Unusual Task For FDA Advisory Committee Goes Well For VEGF-Inhibitor

Prevision Policy Clips | FDA’s Wilson Bryan To Discuss Evolution Of OTAT To Super Office At Feb. 13 Biopharma Congress

FDA Plans To Finalize OTC “Safe Use” Pathway In 2023, Updated Regulatory Agenda Says

FDA’s Very Big Year: A Guide To Legislation Enacted In 2022

FDA Chiefs Chat: Former Commissioners Debate Impact Of IRA On Drug Development, Linking Accelerated Approval To Reimbursement

Prevision Policy Clips | Missouri Rep. Jason Smith Will Chair House Ways and Means Committee

FDORA Odds And Ends: COVID Product Transition Will Be Test Case For RWE; FDA Operations Addressed Via Numerous Provisions

Highlights From UCSF-Stanford CERSI Summit: FDA’s Califf’s On Legislative “Victories,” CMS On Lecanemab Path To Coverage, Orbis for Gene Therapy?

Prevision Policy Clips | Eisai/Biogen Lecanemab (Leqembi) Clears FDA, But Medicare Coverage Will Await

FDA Advisory Committee Trends: Rejections Continue To Dominate In 2022; Will Climate For Sponsors Change In 2023?