Niemann Pick Advocates Push For Regulatory Flexibility, But FDA Stands Firm On Need For Placebo Controls

FDA “Enterprise Modernization” Needs More Funding To Move Past Pilot Stage; Inspections Are Early Focus Of Woodcock’s Priority Project

CBO Codas On Pricing Bill: Impact On Generic Drug Launches Not Analyzed, Budget Office Tells GOP Leaders; “Premium Stabilization” Is Key Variable For Part D Overhaul

Prevision Policy Clips | Sinema Says “Yes”: Drug Pricing Reform Likely To Pass Senate In Coming Days

FDA Advisory Committee “Update” May Result In More Meetings – And Re-Reviews When New Information Comes In, Califf Says

Prevision Policy Clips | FDA Opioid Framework Coming In Two Weeks: OTC Naloxone Carries “Complicated” Cost Issues, Commissioner Rob Califf Says

Prevision Policy Clips | Coherus Cimerli Interchangeable Biosimilar Approval To Lucentis

CMS New Technology Add-On Payments: Class Of 2023 Is Small, With Just Three New Products Qualifying For NTAP Status; Uplizna Rejected, Most Other Applicants Deferred

Prevision Policy Clips | OCE Project Optimus Dose Selection Initiative Cited By Allarity Therapeutics

FDA Public Tracking For Upcoming Externally-Led PFDD Sessions: Inborn Errors Of Metabolism, Neurology Conditions To Be Discussed Soon

Prevision Policy Clips | Part D Premium Deflation Sets Ironic Backdrop For “Inflation Reduction Act”

ctDNA Meta-Analysis Can Provide Valuable Foundation For Use As Early Endpoint But Prospective Trials Still Preferred By FDA

Advisory Committee Tracker: Accelerated Approval In The Spotlight With Precedent-Setting Reviews Coming In Oncology, ALS And DMD

FDA Will Feel Effects Of User Fee Legislation Delays In “Early September” Commissioner Califf Warns; Hiring and Product Reviews Are Immediate Concerns

Prevision Policy Clips | CMS Seeks Ideas To Improve Medicare Advantage; Prior Authorization

Patient Experience Data In Label Depends On Endpoints Relevant To Patients – And MoA Of Therapy; Industry Says FDA Guidances Are Key Step For Using Social Media Data

“Project Site Selector”: FDA Oncology Office Launches Initiative To Increase US Enrollment In Clinical Trials

Do Or Die For Drug Pricing Reform: “Inflation Reduction Act” Emerges In Senate; Close Votes Ahead But Enactment Looks Likely

Prevision Policy Clips | PTO/FDA Coordination Bill Clears Committee By Voice Vote; Judiciary Chair And Lead Sponsor Durbin Has Covid

Prevision Policy Clips | FDA/PTO Collaboration: Senate Committee Will Consider Bill To Create “Inter-Agency Task Force”

Prevision Policy Clips | Another ALS Advisory Committee Coming In 2022: Biogen NDA For Tofersen

Oncology Patient-Reported Data: FDA Urges Sponsors To Collect PROs In Early Trials—Including Open-Label Trials

Prevision Policy Clips | Paxlovid For POTUS: Pfizer COVID Antiviral Has Another High Profile Patient

Gene/Cell Therapies Not Suited To “Real Time” Review, FDA Says In Draft Guidance On RTOR

Remote Regulatory Assessments: FDA Draft Guidance Keeps Bright Line Between RRAs and “Inspections” – But Agency Sounds Keen To Use RRAs Broadly Going Forward