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Prevision Policy Clips | Iilun Murphy Is Permanent OGD Director, CDER's Corrigan-Curay Will “Assume Oversight” Of Generic Drugs

June 9, 2023

Prevision Policy Clips | Intarcia Continues Fight For Exanatide Twice-Yearly: FDA Will Hold September Endocrinologic And Metabolic Drugs Advisory Committee Hearing

June 8, 2023

Eisai/Biogen’s Leqembi Headed Toward “Full” Approval In Alzheimer’s: FDA Support Is Unequivocal; Committee Makeup All But Assures Positive Vote

June 7, 2023

Prevision Policy Clips | Merck Constitutional Challenge Of IRA Drug Price Negotiations

June 7, 2023

FDA “Advancing RWE” Initiative Offers “All Hands On Deck” Review Of Real-World Data Proposals; First Selections Have Been Made, Details To Come

June 6, 2023

AZ/Sanofi’s Nirsevimab For RSV: FDA Highlights Demonstrated Efficacy Better Than Synagis, Few Safety Concerns Ahead Of June 8 Advisory Committee Review

June 6, 2023

Prevision Policy Clips | BrainStorm Says Filed-Over-Protest NurOwn ALS Cell Therapy Will Get FDA Panel Review September 27

June 6, 2023

Prevision Policy Clips | J&J COVID Vaccine Withdrawn From US; FDA Formally Revokes EUA

June 5, 2023

FDA Migraine Prevention Draft Guidance Confirms Separate Trials For Episodic And Chronic Indications; Recent Approvals Have Incorporated That Approach

June 2, 2023

Prevision Policy Clips | Former CMS Chief Of Staff Mandy Cohen To Be Next CDC Director

June 2, 2023

Prevision Policy Clips | Leqembi Coverage Will Be Supported By “Nationwide, CMS-Facilitated Portal”

June 1, 2023

Prevision Policy Clips | OCE Director Pazdur “Exploring Temporary Importation” Of Cancer Drugs In Shortage, Raises Idea Of “Buffer Stockpile”

May 31, 2023

FDA Patient Medication Information Proposal Includes Five-Year Phase-In For All Drugs To Have One-Page Summaries; Best Practices Partnership Suggested Rather Than Consumer Testing Mandate

May 30, 2023

Advisory Committee Tracker: AstraZeneca/Sanofi RSV Antibody, COVID Booster Strategy Meetings Highlight June Agenda

May 30, 2023

Prevision Policy Clips | FDA Patient Medication Information Proposed Rule: Will Third Time Be A Charm?

May 30, 2023

Prevision Policy Clips | FDA Adjusting For Covariates In RCTs Guidance: Recap Podcast

May 26, 2023

HbA1c Affirmed As Diabetes Endpoint Of Choice In New FDA Draft Guidance; Agency Offers Approaches To Incorporate Hypoglycemia Reduction

May 25, 2023

PBM Bills Advance In House As Part Of PATIENT Act; 340B Transparency, Gene Therapy Medicaid/VBP Measures Also Clear E&C Committee

May 25, 2023

Prevision Policy Clips | Diabetes Drug Efficacy Guidance: Hemoglobin A1c Is “The Accepted Primary Endpoint,” Hypoglycemia Incidence Reduction “Advantage”

May 25, 2023

Medicaid Price Negotiation? CMS Proposes “Survey” Process For High-Cost/High-Spend Drugs As Tool To Encourage Price Concessions; Rule Includes Numerous Other Rebate Program Tweaks

May 24, 2023

Artificial Intelligence Will Be Key In Helping FDA Streamline Next-Gen Cell Therapies; “Great Advances” Coming In Next 10 Years

May 24, 2023

How Can FDA Advance Cell Therapy R&D? Issue Guidance in “Real Time,” Encourage Collaboration With Industry, CBER’s Marks Says

May 24, 2023

Prevision Policy Clips | Medicaid “Price Verification Survey” Proposal Seeks To Apply Pressure For Supplemental Rebates/VBP Agreements

May 24, 2023

Intercept OCA NASH Indication Will Wait For Outcomes Data; Attempt To Win Committee Support For Accelerated Approval By Cutting Target Market Fails

May 23, 2023

“Platform” Pathway Will Not Be “One Size Fits All,” FDA Says; CAR-T Therapies May Be Early Models For Leveraging Data Across Products, FOCR White Paper Suggests

May 23, 2023
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