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FDA Rounds Out PFDD Guidance Series With Recommendations For COA-Based Endpoint Development, Specific Advice For Heterogeneous Conditions
April 6, 2023
PBM Transparency Featured At Senate Finance Committee Hearing; Wyden Looks Ready To Tackle “Big-League” Issue On “Bipartisan Basis”
April 6, 2023
Can FDA Save The Generic Industry? Chronic Shortages Are “Sign Of Strains” Facing Sector, CDER Director Warns; Statutory Update May Be Overdue
April 6, 2023
CDER Hiring “Doing Very Well,” Director Cavazzoni Says, Especially For Medical Officers: Still Needs For Stats And Inspectors; OTC Office Set To Rebound
April 6, 2023
Prevision Policy Clips | CMS Final Part D Rule Harmonizes “Gross” Drug Spending Definition
April 6, 2023
CBER Stepping Up Effort As Regulator/Stimulator Of Gene Therapy Commercial Efforts; Marks Says It Is Frustrating To See Late-Stage Projects Dropped
April 6, 2023
Prevision Policy Clips | CBER Director Marks Expects Pace Of Gene Therapy Approvals To Jump Substantially
April 5, 2023
Advisory Committee Tracker: Rexulti For Alzheimer’s Agitation, Long Awaited NASH Review Among Half Dozen New Topics Added By FDA
April 4, 2023
Prevision Policy Clips | Opioid “Mail-Back” Program Will Be Added To REMS
April 4, 2023
Prevision Policy Clips | CMS Updated List Of Part B Inflation Rebate Drugs No Longer Includes CAR-T Therapies
April 3, 2023
FDA Initiates PDUFA VII Digital Health Technologies Program: Workshop Highlights Early Progress, Framework Identifies Future Priorities
March 31, 2023
Prevision Policy Clips | Drug Pricing Legislation That Would Apply Inflation Rebates To Private Insurance Market, Move Baseline Year To 2016 Introduced
March 31, 2023
iPLEDGE 19-Day “Lockout” Period For Isotretinoin Patients Should Be Dropped, FDA Committee Says; Home Pregnancy Tests Should Continue
March 30, 2023
FDA Foreign Inspections Pilot Program Back On Track Post-COVID, Califf Tells House Budget Hearing; China Visits Will Commence In May
March 30, 2023
Prevision Policy Clips | FDA Establishes Lupus Clinical Trial Initiative
March 30, 2023
Prevision Policy Clips | Otsuka/Lundbeck Rexulti For Alzheimer’s Agitation Gets FDA Advisory Committee Review
March 29, 2023
Prevision Policy Clips | OTC Switch Of Contraception Drug Opill Advisory Committee Rescheduled And Expanded
March 28, 2023
Prevision Policy Clips | BrainStorm Says FDA To Convene Advisory Committee For RTFed NurOwn Cell Therapy For ALS
March 27, 2023
iPLEDGE REMS Review: FDA Floats End To Use Of At-Home Pregnancy Tests, But Wants Committee To Consider Loosening Other Isotretinoin Requirements
March 24, 2023
Oncology Accelerated Approval Policy Put In Writing: Randomization Is “Preferred,” FDA Says In Draft Guidance, But Plenty Of Exceptions
March 24, 2023
Drug Shortages Back In Congressional Spotlight: FDA “Essential Medicine” List May Need Rethinking, Quality Ratings Get A Boost From Testimony At Senate Hearing
March 24, 2023
Prevision Policy Clips | Accelerated Approval In Oncology: RCTs Preferred To Single-Arm Studies, FDA Confirms
March 24, 2023
HHS Intends To Conduct Part D Price Negotiations With Public Scrutiny, Secretary Becerra Tells Initial Capitol Hill HHS Budget Hearings
March 23, 2023
“March In” Debate Put On Back Burner, But Xtandi May Still Be Precedent In First Round Of Price Negotiation
March 23, 2023
Biogen/Ionis’ Tofersen For ALS Headed Toward Accelerated Approval; FDA Panel Confirms NfL As Surrogate Marker, But Not For “Full” Approval
March 23, 2023
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