Advisory Committee Tracker: Amylyx ALS Drug AMX0035 Gets A Second Chance; Is FDA Applying Lessons Learned From Aduhelm?

PFDD Public Meeting Features Products, Indications Supported By Guidances “1 and 2”; FDA Reviewer Says Dupixent EoE Approval Not Possible Without PFDD Guidances

Patient-Focused Clinical Outcome Assessments Are Not “PRO-Centric,” FDA Says; PFDD Guidance On Selecting COAs Is Designed To Extend Options

Prevision Policy Clips | FDA Updates Track And Trace Draft Guidances Ahead Of November 2023 Deadline

Prevision Policy Clips | COVID Booster For Fall Will Be Bivalent With Omicron BA.4/5 Component, FDA Confirms

Prevision Policy Clips | Zelnorm Withdrawn Again - This Time for Business Reasons

FDA Was Making Progress On Foreign Inspections Pre-COVID, OIG Finds; “Hybrid Inspection” Pilot Program Complements Agency Self-Improvement

Omicron-Variant COVID Boosters Endorsed By FDA Advisory Committee: FDA Will Likely Seek Bivalent Booster With Current Strain Plus BA.4/5 Variant

Prevision Policy Clips | PFDD Clinical Outcome Assessment Draft Guidance From FDA

Continuous Manufacturing Submissions Achieve FDA Approval Nine Months Ahead Of Batch Manufacturing, FDA Analysis Finds

Bluebird’s Beti-cel Reduction Of Patient Treatment Burden Sways ICER Panel; Sets Stage For Next Gene Therapies To Supplant Current Treatment Regimens

Oligonucleotide Development: FDA Clinical Pharmacology Guidance Emphasizes Liver And Kidney Function Impact

Prevision Policy Clips | CMS “Enhancing Oncology Model” Narrows Focus Of Existing Medicare Oncology Management Pilot To Seven Cancers

FDA External Controls Guidance Will Not Be “One-Size-Fits-All”; Agency Reviewing And Incorporating “Thousands” Of Comments To Initial RWE Guidance Set

OTC “Safe Use” Pathway Emerges At Last: FDA Proposal Has New Acronym – “ACNU,” Not “NSURE”; Commercial Landscape Has Changed Dramatically Since Idea First Floated

Prevision Policy Clips | FDA Proposes New OTC Pathway At Long Last: “NSURE” Re-Framed As “ACNU”

Prevision Policy Clips | Cell & Gene Therapies Safety Project, Rare Neurodegenerative Diseases Task Force Part Of FDA ALS Action Plan

Rescinding “Breakthrough Therapy”: Accelerated Approval Of Another Drug Not Enough To Take Away BTD, FDA Guidance Says

Prevision Policy Clips | Breakthrough Therapy Guidance Lists Three Considerations For Rescinding Designation Including A Different Drug Approved

FTC/DOJ Antitrust Workshop Puts Large-With-Large Biopharma Mergers In Crosshairs; PBM Contracts, Formulary Position Should Be Watched Closely

Prevision Policy Clips | “Rebate Rule” Delay Is Funding Source For Bipartisan Gun Legislation

Prevision Policy Clips | Makena AA Withdrawal Hearing Questions Include Final Vote On Whether Drug Should Remain Available While “Appropriate”

Acadia’s Nuplazid For Alzheimer’s Psychosis Fails On De Facto Appeal; FDA Psychopharm Panel Agrees With FDA That Another Trial Needed In ADP

Prevision Policy Clips | FTC Unanimously Votes To Increase Scrutiny Of Insulin Rebate Practices

CBER Pursuing Operation Warp Speed For Rare Diseases, But Staffing Challenges Preclude Progress; OTAT Director Bryan Is “Reconsidering” Review Office Structure