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Prevision Policy Clips | PDUFA Reauthorization Kick Off Meeting Set For July 14
May 8, 2025
Opioid Post-Marketing Studies Praised For “Rigor,” But FDA Committee Wary Of Labeling Changes; Discussion Highlights Ongoing Concerns About Long-Term Efficacy
May 7, 2025
HHS Deputy Nominee O’Neill Cites Value Of AI, Support For Medicare Drug Price Negotiation And Vaccines During Confirmation Hearing; RFK “Doing A Great Job”
May 7, 2025
Prevision Policy Clips | FDA Schedules Last-Minute ODAC Review Of Four Oncology Drugs May 20-21
May 7, 2025
CBER Director Vinay Prasad Solidifies FDA’s Anti-Industry Identity, Brings Increased Scrutiny To Use Of Accelerated Approval In Cancer, Gene Therapies
May 6, 2025
White House Drug Manufacturing EO Seeks To Streamline Domestic Site Inspections, Accelerate Foreign Audits – But RIFs, Long-Standing Challenges Will Be Reality Check
May 6, 2025
Prevision Policy Clips | FDA Directed To Streamline Domestic Inspections, Accelerate Foreign Ones
May 6, 2025
Prevision Policy Clips | FDA Not Mentioned In “Skinny Budget” Unveiled By Trump Administration May 2
May 5, 2025
BIOSECURE Likely to Be Reintroduced Soon In Modified Form; China-Focused Biotech Bills Could Proliferate In 2025
May 2, 2025
Prevision Policy Clips | NIH “Generation Gold Standard” Vaccine Initiative Targets 2029 FDA Submissions For Two Universal Flu
May 2, 2025
Price Negotiation Year Two: CMS Town Hall Shows Little Change In Tone Under Trump; Ozempic, Trelegy Ellipta, And Xifaxan Get Mixed Comments
May 1, 2025
FDA Opioid Advisory Committee Will Consider Labeling Changes To “Quantify” Risks Based On Post-Marketing Trials; First Panel Of Kennedy/Makary Era Will Still Include Industry Rep
May 1, 2025
House Energy & Commerce Committee Advances Six Bipartisan Health Bills; PBM And PRV Measures Remain TBD
May 1, 2025
FDA Deadline Tracker: Missed Deadlines Make News In April After Layoffs To Start The Month
May 1, 2025
Prevision Policy Clips | Alliance For A Stronger FDA Applauds Commissioner Makary’s Decision To Drop Reorg Plan
May 1, 2025
Prevision Policy Clips | HHS Deputy Nominee O’Neill Confirmation Hearing Set For May 6
April 30, 2025
FDA Reorg Plan Will Not Move Forward, Commissioner Makary Says; “Single Center” Idea Appears Dead For Now: Possible Turning Point For FDA Under Trump?
April 29, 2025
Advisory Committee Tracker: COVID Booster Panel Could Be Tone-Setter For Makary’s Tenure – If It Happens; FDA Public Meeting Cancellations Continue Into Spring
April 29, 2025
Prevision Policy Clips | No FDA Reorganization Planned, Commissioner Makary Says
April 29, 2025
Prevision Policy Clips | Novavax COVID Vaccine Delay: Commissioner Makary Confirms Demand For Clinical Trial
April 28, 2025
Prevision Policy Clips | Merck, Bristol Reassure Investors That FDA Reviews Are Proceeding On Time For Now
April 25, 2025
340B Contract Pharmacy Restrictions’ Impact Is Waning, Manufacturers Tell Sen. Cassidy; Report Quantifies Effect On Lilly, J&J, And Amgen, Fuels Cassidy’s Call For Reforms
April 24, 2025
FDA Expands Catalogue Of Rare Disease Case Studies: New Examples Look At Surrogate Endpoints (Qalsody, Nexviazyme, Livdelzi), Externally Controlled Trials (Amvuttra) And Novel COAs (Bylvay)
April 24, 2025
Making “Cost-Effective” Drugs “Affordable”: ICER Obesity White Paper Offers Options To Expand Access To GLP-1s For Insurers, Policymakers To Consider
April 24, 2025
Prevision Policy Clips | FDA Rare Disease Case Studies Include Biogen’s Qalsody And Alnylam’s Amvuttra
April 24, 2025
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