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

July 5, 2022

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

July 5, 2022

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

July 5, 2022

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

July 5, 2022

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

July 1, 2022

Prevision Policy Clips | Zelnorm Withdrawn Again - This Time for Business Reasons

June 30, 2022

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

June 29, 2022

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

June 29, 2022

Prevision Policy Clips | PFDD Clinical Outcome Assessment Draft Guidance From FDA

June 29, 2022

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

June 29, 2022

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

June 28, 2022

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

June 28, 2022

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

June 28, 2022

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

June 27, 2022

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

June 27, 2022

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

June 27, 2022

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

June 24, 2022

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

June 23, 2022

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

June 23, 2022

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

June 22, 2022

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

June 22, 2022

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

June 21, 2022

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

June 18, 2022

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

June 17, 2022

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

June 16, 2022
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