FDA Inspection Authority Provisions In FDORA May Help Make 2023 A Happy New Year For Agency

Prevision Policy Clips | Narcan OTC Will Be Reviewed By FDA Advisory Committee: Broader Implications

Eylea Pediatric Use: FDA Asks Committee For Closer Look At Proposed Label For Infant Retinopathy; Agency May Want More Post-Treatment Monitoring

Advisory Committee Tracker: Another Unusual ODAC Set For February; COVID Vaccines, iPledge REMS Will Also Be Topics Early In 2023

Prevision Policy Clips | Seven Years’ War: Fabre-Kramer Submits NDA Amendment For Gepirone Seven Years After Dispute Resolution

Prevision Policy Clips | REMS Content & Format Final Guidance From FDA

Aduhelm Congressional Report Provides Anticlimactic Coda To FDA Controversy; Clarifying Use Of “Point/Counterpoint” Briefing Document May Be One Outcome

CMS New Technology Add-On Payment Applications For FY 2024 Include Five Bispecific Antibodies Among 20 Drug Candidates; Likely Rebound After Small Class Of 2023

Prevision Policy Clips | FDA Novel Therapeutics Approvals In 2022

Prevision Policy Clips | FDORA Set To Become Law

FDORA Clinical Trial Provisions Are Jumping Off Point For FDA Priority Under Califf: Diversity Is Main Political Theme; “Decentralized” And “Seamless” Guidances Will Be Key For Industry

“Platform Technologies” Pathway Will Be Important New FDA Tool In 2023; Sen. Burr’s Parting Gifts Include Stripping “Anti-Innovation” Amendments From FDA Year-End Package

Prevision Policy Clips | J&J, Perrigo Among Participants In Briefing With HHS Secretary On OTC Pediatric Cold & Flu Medicines

Accelerated Approval Reforms In FDORA Follow Senate Blueprint; Highlight of “Drugs & Biologics” Section Of Year-End Bill

FDORA Puts Cap On Big Year For FDA: User Fee Riders, PREVENT Pandemic Act Reforms Make Year End Omnibus; “Platform Technologies” Could Be One To Watch

Prevision Policy Clips | GSK Jemperli Rectal Cancer Indication Development Plan Will Be Focus Of Unusual ODAC

ICER Panel Skeptical Of Astellas’ Novel NK3 For Menopause Symptoms; Lack Of Peer Reviewed Data Raises Concerns

Prevision Policy Clips | FDA Reforms Ready To Move In Lame Duck: “FDORA”

FDA Gene Editing Safety Workshop: Targeted Approaches To Screen For Off-Target Effects?

Prevision Policy Clips | Madrigal Pharma To Pursue Accelerated Approval For NASH Drug In First Half Of 2023

Cytokinetics OM For Heart Failure Has Uncertain Future: Large Heart Failure Trial Is Not “Substantial Evidence” On Its Own, FDA Committee Agrees

Prevision Policy Clips | FDA’s VRBPAC To Meet Jan. 26 To Discuss “Future Vaccination Regimens” For COVID, Still Virtual

Sentinel Pregnancy Data Work Under PDUFA VII May Be Key Step In Moving FDA Active Surveillance System Beyond Supporting Role; EHR Integration Is Longer-Term Opportunity

OCE’s “Project Renewal” Concludes First Label Update – After Four Years: Genentech Xeloda Has Eight New And Revised Indications

Prevision Policy Clips | CMS Delays Initial Decision On Updating Beta Amyloid PET Scan Coverage Policy