Prevision Policy Clips | Former FDA Commissioners Urge Quick Action On Califf Nomination In Light Of Ongoing Pandemic

Medicare Coverage For Alzheimer’s mABs: CMS Evidence Review Complete For NCD, Proposal On Track For January

Prevision Policy Clips | Senate BBB Language: Plasma-Derived Therapies Would Be Exempt From Price Negotiation

FDA’s Capstone Guidance On RWE Reinforces Key Themes Of Prior Documents, Notes Obligation To List Studies On ClinicalTrials.gov

Prevision Policy Clips | Lilly/Innovent PD1 Inhibitor Advisory Committee Date Set: Test Case For Chinese Development

BARDA Flu Investments Shift Away From Antivirals, Towards “Pathogen-Agnostic” Treatments Like Pulmonary Therapies

Reata Bardoxolone Headed To FDA Rejection After Unanimous “No” Vote By Committee; New Study In Alport Syndrome Needed With Longer Washout Period

Prevision Policy Clips | FDA/CMS “Continuous Evaluation” Of Medical Interventions Can Be Reality, Former Deputy Commissioner

Medicare Drug Price Negotiation “Skill Set” Ready To Be Built, CMS Deputy Blum Says; Part D Redesign Will Be A “Game Changer”

Prevision Policy Clips | FDA Commissioner Confirmation Hearing Set For December 14

FDA N-of-1 IND Guidances For Antisense Oligonucleotides Define Program For Adapting To Unique Variants; Drug Center Issues Clinical, CMC Drafts

ICER “Exploratory” Fair Access Report Claims Relatively Smooth Access For Treatments It Deems Cost Effective; Some Signs Payors Want ICER Approval

Prevision Policy Clips | FDA “Bespoke” Antisense IND Guidances Cover Clinical And CMC Considerations

FDA Gene Therapy Office Under Strain: OTAT Plans Less Individual Attention, More “Group Communication” Due To Workload

Reata Bardoxolone Looks Like A Washout: FDA Agrees Pivotal Trial Is Positive – But Flawed Design Means Efficacy Remains Uncertain; COVID Impact Lingers In Background

Prevision Policy Clips | Pfizer, Lilly, AbbVie Update JAK Inhibitor Labels To Incorporate New Warnings

Prevision Policy Clips | Fentanyl Analogue Scheduling Proposal Would Allow Research Into Non-Addictive Substances: "Those Exist"

Artificial Intelligence Is New Priority For FDA FY22 Generic Drug Research Program

Prevision Policy Clips | Patient Advocacy Support For Califf FDA Nomination In Senate Expressed In Letter

Advisory Committee Tracker: FDA Cancels One ODAC Accelerated Approval Review Meeting – But May Be Prepping Another

Merck Gets Molnupiravir Over The Line: FDA Panel Recommends EUA For COVID Oral Antiviral For Non-Hospitalized Patients At High-Risk To Progress

Prevision Policy Clips | Secura Bio Withdraws Farydak For Multiple Myeloma Nearly Seven Years After Accelerated Approval

340B Payment Cuts In Medicare Part B: Supreme Court Oral Arguments Run Against HHS; Key Question May Be How Much Discretion HHS Will Lose

Prevision Policy Clips | ODAC Review Of Farydak, Marqibo “Delinquent” Accelerated Approvals Canceled: Are OCE's Warnings Working?

FDA Registry Guidance To Advance RWD/RWE Collection Emphasizes Effort To Assure That Registry Represents Right Group To Study For Regulatory Decisions