Renal Cell Carcinoma, Bladder Cancer FDA Guidances Take Similar Approaches On DFS Endpoint, Trial Designs

Prevision Policy Clips | FDA Publishes “EUA-Plus” Guidance In Different Form: Oct. 22 COVID Vaccine Committee Briefing Document

Makena Withdrawal Sought By FDA: “Integrity Of Accelerated Approvals” One Factor Cited In Notice; AMAG/Covis Could Seek Hearing, Delay Action By 6-12 Months

PDUFA VII Negotiations Begin: CBER Resources Is One Shared Priority; Industry Wants COVID-19 “Lessons Learned” On The Table

Time For REMS User Fees? IG Report, FDA Response Lay Out Possible Agenda For Overhaul Of Risk Management Oversight At Agency

Prevision Policy Clips | Regeneron, Gilead Have High-Profile Patient For Unapproved COVID-19 Therapies

340B Rollback Hits Its Limit: Manufacturer Gains Unlikely To Expand Further Until After Elections

Vaccine RWE Studies For Label Changes: FDA Wants To Back-Check Analyses; Merck Zostavax Experience Took Time But Shows Agency Flexibility

Opioid Use Disorder Treatments: FDA Final Guidance Incorporates Broader, “Public Health” Risk/Benefit Framework, Embraces Less Stigmatizing Language

Prevision Policy Clips | Mesoblast Gets CRL From FDA For Rynocil Cell Therapy Despite Lopsided Positive ODAC Vote

Drug Price Hearing Day Two Puts Amgen, Mallinckrodt And Novartis In Hot Seat: Rebate Message Gains Some Traction, But Canadian Price Disparity Still Stings

Clinical Trials Post-COVID Will Require “Serious Soul-Searching,” FDA’s Woodcock Says; More Robust Process Needed That Reaches Beyond Major Centers

Prevision Policy Clips | Opioid Use Disorder Treatment: FDA Final Guidance For Drug Development Incorporates Broader Risk/Benefit

Drug Price Hearing Spotlights Revlimid And Copaxone: Detailed Investigation Feels Behind The Times

FDA Surveillance Systems Will Fill Gaps In COVID-19 Safety Data, CBER’s Marks Says; Further Guidance On Vaccine EUAs May Not Be Coming After All

ICER White Paper Defines Criteria For “Fair Patient Access;” New Work Group Will Produce Annual Report On Major US Payer Performance

Prevision Policy Clips | Seven Former FDA Commissioners Warn Against White House Interference With Scientific Process

Ulcerative Colitis Step Therapy Is Too Influenced By Other Diseases, Patient Groups Tell ICER; Payer Restrictions Should Reflect Treatment Practices In UC

Prevision Policy Clips | BSUFA Kickoff Meeting Scheduled For November 19

Advisory Committee Tracker: FDA Prepares For Biggest Meeting Ever In October (COVID Vaccine Standards); Sets Nov. 6 Date For Aducanumab For Alzheimer’s

Prevision Policy Clips | Biogen Aducanumab Alzheimer’s Treatment Advisory Committee Set For Nov. 6

FDA’s Digital Health Center of Excellence Will Not Accept Or Approve Applications; “Single Hub” For Health Tech Gets No New Funding

DoD “Operation Warp Speed” Team Developing Computer Platform “Tiberius” To Help Local Entities On Planning, Administration Of COVID-19 Vaccines

Rx Importation Final Rule: Will The Precedent Survive The Politics?

Prevision Policy Clips | Rx Import Final Rule Released: Takes Effect After November Election, With Additional Lag Time For FDA Review