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We’re Not In Kansas Anymore: CMS Nominee Oz Brings Unpredictability To Medicare Program; Round 2 Of Drug Price Negotiations Will Be Early Anti-Corporate Test
November 20, 2024
Prevision Policy Clips | Trump Embraces Telehealth? TV’s “Dr. Oz” Is Choice For CMS Administrator
November 20, 2024
FDA Caught Between Kennedy And Conservative Courts: Three Thorny Issues Will Test Agency’s Ability To Face Institutionalized Second-Guessing In 2025 And Beyond
November 19, 2024
AZ Andexxa Confirmatory Trial Questioned By FDA: AdComm To Discuss Thrombosis Risk, Lack Of Long-Term Benefit; Additional Trial May Be Next Step
November 19, 2024
Prevision Policy Clips | FDA Commissioner Speculation: Ohio Republican Rep. Wenstrup Said To Be Interested
November 19, 2024
FDA’s Gene Therapy Primer: FAQ Draft Guidance Addresses Common Questions For Cell/Gene Therapy Development; Fulfills PDUFA Commitment
November 18, 2024
FDA Sentinel Safety System Adjusting To “Hard Truths” Of Budget Uncertainty; Focus Will Be Operations, Not New Initiatives, Going Forward
November 18, 2024
Lilly Product Reclassification Campaign Expands To siRNA; FDA “Biologics” Definition Could Be Key Theme In 2025
November 18, 2024
Prevision Policy Clips | Gene Therapy FAQs: FDA Releases Draft Guidance
November 18, 2024
Clozapine REMS Review: FDA Committee Will Decide If Program Can Be Pared Back – Or Eliminated – Given Experience During Decade Of “Enforcement Discretion”
November 15, 2024
Prevision Policy Clips | Through The Looking Glass: RFK Jr. Is Trump’s Pick For HHS Secretary
November 15, 2024
Through The Looking Glass: RFK Jr. Is Trump’s HHS Pick
November 14, 2024
Oligonucleotide Nonclinical Safety Assessments: FDA Draft Guidance Addresses “Unique Challenges” With Category, Including Risk Of Off-Target Binding
November 14, 2024
OS As A Safety Endpoint In Oncology: Simulations And Modeling May Be Key To Adding “Rigor” To Assessing Immature OS Data, FOCR Panelist Says
November 14, 2024
Prevision Policy Clips | CBER Director Peter Marks Resolute In Face Of RFK Jr. Vaccine Questions With AdComms A Possible Solution, Sounds The Alarm On Bird Flu
November 14, 2024
Prevision Policy Clips | Circulating Tumor DNA As Intermediate Endpoint In Oncology Trials: FDA “Very Encouraged”
November 13, 2024
“Project Pragmatica” May Gain Traction For Post-Marketing Studies, Including Trials Not Aimed At FDA, Oncology Sponsors Indicate During FOCR Meeting
November 12, 2024
FDA Mass Exodus? It’s Too Early To Measure Impact Of Trump’s Win On Staff, Califf Says; Offers Wish List For Next Commissioner
November 12, 2024
Prevision Policy Clips | Senate Health Committee Chair Likely—But Not Certain—To Go To Cassidy
November 12, 2024
“Lame Duck” Session Could Still Be Eventful For Biopharma; Initial Post-Election Read Is To Anticipate Short-Term CR Through March, Unless Trump Wants Clean Slate For 2025
November 8, 2024
Prevision Policy Clips | REMS Logic Models Useful for Drugs That Aren’t First-to-Market in a Class
November 8, 2024
Prevision Policy Clips | RFK Jr Would Clear Out Senior FDA Officials “In Certain Categories” Like Nutrition
November 7, 2024
Trump II: People To Watch And Key Questions For Biopharma During The Upcoming Transition
November 6, 2024
Prevision Policy Clips | IRA Repeal A Possibility If Republicans Sweep By Taking The House, Following Trump's Victory
November 6, 2024
Prevision Policy Clips | FDA Expands STAR Real-Time Review Pilot: Novel Applications May Be Submitted For Program Participation Dec. 2
November 5, 2024
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