Part D “Preferred” Specialty Tier Finalized By CMS; Agency Also Codifies And Clarifies Specialty Tier Formulas

Prevision Policy Clips | David Kessler To Lead Biden Vaccine Team, Not FDA

FDA Commissioner Choice Will Be Janet Woodcock, According To Some Familiar With Process, Though Nothing Final

Prevision Policy Clips | FDA’s Woodcock To Be Acting Commissioner At Outset Of Biden Term

Prevision Policy Clips | CMS "Reasonable and Necessary" Coverage Definition Expands To Include Commercial Market Considerations

FDA And AI: Digital Health Center of Excellence Issues Machine Learning Plan In Response To High Volume Of Marketing Submissions; Guidance Coming

Prevision Policy Clips | HHS/FDA Turf War Continues In Waning Days Of Trump Administration: Acting Chief Counsel

Tennessee Medicaid Formulary: Precedent Or Poison Pill?

Prevision Policy Clips | Moderna Half-Dose COVID Vaccine Efficacy Data Will Be Reviewed By FDA, Commissioner Hahn

CDER Reorganizes Five Offices: OSE To Have New Premarket Focused Divisions, OGD Will Have Safety And Clinical Evaluation Office

Prevision Policy Clips | Provention Bio Teplizumab For Type 1 Diabetes Scheduled For May 27 FDA Advisory Committee

FDA Advisory Committee Trends: COVID Era Brings Fewer, Tougher Reviews; Panels Voted “Yes” Just 50% Of The Time In 2020

Prevision Policy Clips | Senate Switch To Democratic Control Changes Drug Pricing Reform Dynamics

Generic Label Modernization Provision In Spending Bill Gives FDA Authority To Mandate Updates After Notification-And-Response Mechanism

Prevision Policy Clips | OTC Monograph Fees Await Resolution Of Hand Sanitizer Issues: HHS’ Latest Notice

Rx Rebate Reports Mandated By Year-End Spending Bill Could Reopen Debate Over Future Of Pricing Tool – But Not Until 2023

FDA Neurodegenerative Gene Therapy Guidance: Alzheimer’s, ALS Trials Would Need Placebo Control; Innovative Designs Possible for Spinal Muscular Atrophy

FDA Antisense Oligonucleotide Guidance Series Kicks Off With Draft Guidance On IND Submissions; CMC ASO Guidance Probably Next

Value-Based Purchasing And Medicaid: CMS Sees Gene Therapy, Accelerated Approval Drugs As Good Starting Points; Final Rule Retains Broad Scope – And Ambiguity

Prevision Policy Clips | Gene Therapies For Neurodegenerative Diseases: FDA Draft Guidance

Advisory Committee Tracker: A Rare Keytruda Review In Otherwise Quiet Start To 2021

Prevision Policy Clips | Part B “Most Favored Nation” Pricing Demo Blocked On Three Separate Fronts

Prevision Policy Clips | ODAC To Review Keytruda Feb. 9 For New Breast Cancer Indication

Gene Therapy PFDD, Evidence Standards For Expedited Pathways Guidance Proposed By Industry As PDUFA VII Talks Continue

Medicaid Line Extension Rebate Rule Finalized With Combos Excluded And Effective Date Delayed; Value-Based Pricing Provisions Largely Unchanged