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Prevision Policy Clips | CBER/CDER Digital Health “Framework” Kicks Off PDUFA VII Process

March 23, 2023

Moderna Survives Pricing Hot Seat: COVID Vaccine Access Pledge Plays Well In Senate Hearing; Price Justification Helped By Overwhelming Value Case

March 22, 2023

Prevision Policy Clips | HHS Plans “March In” Workshop To Discuss Role Of Price In Patent Reviews; Xtandi Spared Proceedings For Now

March 22, 2023

FDA’s “Project FrontRunner” Could Speed Adoption Of New Endpoints For Oncology AA; “Project Pragmatica” Offers Path To Pursue New Regimens

March 21, 2023

Prevision Policy Clips | FDA Division Of Neurology I Acting Deputy Director Is Emily Freilich

March 21, 2023

ICER Says Lecanemab Has Insufficient Net Health Benefit, “Low” Long-Term Value At Current Pricing; Post-Approval Evidence Will Be Key, But How?

March 20, 2023

“Conditional Approval” Redux? FDA Gives Advisory Committee “Two Scenarios” For Biogen/Ionis’ Tofersen In ALS: Accelerated Approval Or Full Approval

March 20, 2023

Prevision Policy Clips | CDER Office Of Compliance Annual Report

March 20, 2023

Biomarker Studies Proposed For Use In Labeling Require Subject-Level Data Submission, FDA Says In Revised PKG Guidance; “Voluntary” Program Ending

March 17, 2023

Opioid Overdose Treatments In Spotlight At FDA Workshop; Agency Hopes To Spread Message That Abstinence Is Not The Only Acceptable Endpoint

March 17, 2023

Paxlovid Endorsed For EUA-To-NDA Approval On Strength Of FDA Reassurances On Efficacy; DDIs Are Main Safety Concern

March 17, 2023

Prevision Policy Clips | Sarepta DMD Gene Therapy Will Go To Advisory Committee Ahead Of May 29 User Fee Deadline

March 17, 2023

CMS Casts Broad Net For Price Negotiation Targets: All NDAs With Same “Active Ingredient” Will Be Covered By “A Single Price”; Tight Timeline For Biosimilar Sponsors To Seek Delays

March 16, 2023

CMS Price Negotiation Benchmarks: Reference Pricing Tied To Therapeutic Alternatives Where Available, FSS Pricing Where Not; “Starting Point” Is Likely Key To Final Price

March 16, 2023

Prevision Policy Clips | CBER Gene Therapy “Super Office”: Witten’s Interim Director Role Likely To Run At Least Into Summer

March 16, 2023

Part B Inflation Rebate List Released By CMS: No Major Products Affected, First Year Collections May Not Reach $20 Million

March 15, 2023

Prevision Policy Clips | FDA Draft Guidance On Long-Acting Local Anesthetics Encourages Data Collection On Opioid Use

March 15, 2023

Pfizer Paxlovid NDA Conversion Complicated By Lack Of Efficacy In Vaccinated Populations; Approval Still Likely Heading To Panel Review

March 14, 2023

GAO Report Spotlights FDA Advanced Manufacturing Initiatives, Urges Agency To Flesh Out Metrics For ETP and FRAME

March 14, 2023

Prevision Policy Clips | Veterans Affairs Department To Cover Eisai/Biogen’s Leqembi For Alzheimer’s But Restricts Use To 65 And Older

March 14, 2023

Get Ready To DANCE: FDA/Duke RWE Negative Controls Meeting Features Two Projects, But Agency Says Activities Are Only At “The Start”

March 13, 2023

Prevision Policy Clips | GAO Advanced Manufacturing Report Spotlights FDA Efforts

March 13, 2023

FDA Proposes Emerging Pathogens Preparedness Program As PAHPA Add-On In Budget “Wish List”; LDTs Not Included In Requests To Congress

March 10, 2023

“Infected Trials,” Remote Inspection Guidances Among 18 CBER/CDER COVID Policies That Will Be Retained Post-Emergency; FDA Outlines Wind-Down Plan For Others

March 10, 2023

Genentech Polivy Wins Strong Support For First-Line DLBCL Claim Despite Skeptical FDA Review; ODAC Losing Streak Over

March 10, 2023
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