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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Prevision Policy Clips | Zelnorm Withdrawn Again - This Time for Business Reasons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Prevision Policy Clips | PFDD Clinical Outcome Assessment Draft Guidance From FDA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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