FDA Rounds Out PFDD Guidance Series With Recommendations For COA-Based Endpoint Development, Specific Advice For Heterogeneous Conditions

PBM Transparency Featured At Senate Finance Committee Hearing; Wyden Looks Ready To Tackle “Big-League” Issue On “Bipartisan Basis”

Can FDA Save The Generic Industry? Chronic Shortages Are “Sign Of Strains” Facing Sector, CDER Director Warns; Statutory Update May Be Overdue

CDER Hiring “Doing Very Well,” Director Cavazzoni Says, Especially For Medical Officers: Still Needs For Stats And Inspectors; OTC Office Set To Rebound

Prevision Policy Clips | CMS Final Part D Rule Harmonizes “Gross” Drug Spending Definition

CBER Stepping Up Effort As Regulator/Stimulator Of Gene Therapy Commercial Efforts; Marks Says It Is Frustrating To See Late-Stage Projects Dropped

Prevision Policy Clips | CBER Director Marks Expects Pace Of Gene Therapy Approvals To Jump Substantially

Advisory Committee Tracker: Rexulti For Alzheimer’s Agitation, Long Awaited NASH Review Among Half Dozen New Topics Added By FDA

Prevision Policy Clips | Opioid “Mail-Back” Program Will Be Added To REMS

Prevision Policy Clips | CMS Updated List Of Part B Inflation Rebate Drugs No Longer Includes CAR-T Therapies

FDA Initiates PDUFA VII Digital Health Technologies Program: Workshop Highlights Early Progress, Framework Identifies Future Priorities

Prevision Policy Clips | Drug Pricing Legislation That Would Apply Inflation Rebates To Private Insurance Market, Move Baseline Year To 2016 Introduced

iPLEDGE 19-Day “Lockout” Period For Isotretinoin Patients Should Be Dropped, FDA Committee Says; Home Pregnancy Tests Should Continue

FDA Foreign Inspections Pilot Program Back On Track Post-COVID, Califf Tells House Budget Hearing; China Visits Will Commence In May

Prevision Policy Clips | FDA Establishes Lupus Clinical Trial Initiative

Prevision Policy Clips | Otsuka/Lundbeck Rexulti For Alzheimer’s Agitation Gets FDA Advisory Committee Review

Prevision Policy Clips | OTC Switch Of Contraception Drug Opill Advisory Committee Rescheduled And Expanded

Prevision Policy Clips | BrainStorm Says FDA To Convene Advisory Committee For RTFed NurOwn Cell Therapy For ALS

iPLEDGE REMS Review: FDA Floats End To Use Of At-Home Pregnancy Tests, But Wants Committee To Consider Loosening Other Isotretinoin Requirements

Oncology Accelerated Approval Policy Put In Writing: Randomization Is “Preferred,” FDA Says In Draft Guidance, But Plenty Of Exceptions

Drug Shortages Back In Congressional Spotlight: FDA “Essential Medicine” List May Need Rethinking, Quality Ratings Get A Boost From Testimony At Senate Hearing

Prevision Policy Clips | Accelerated Approval In Oncology: RCTs Preferred To Single-Arm Studies, FDA Confirms

HHS Intends To Conduct Part D Price Negotiations With Public Scrutiny, Secretary Becerra Tells Initial Capitol Hill HHS Budget Hearings

“March In” Debate Put On Back Burner, But Xtandi May Still Be Precedent In First Round Of Price Negotiation

Biogen/Ionis’ Tofersen For ALS Headed Toward Accelerated Approval; FDA Panel Confirms NfL As Surrogate Marker, But Not For “Full” Approval