“Reasonable Price” Clause Would Return In Biden “March In” Framework: Unwelcome Headline For Innovators, But Draft Sets High Bar For Intervention – And Likely Small Impact If Implemented

Prevision Policy Clips | “Reasonable Pricing” Clause Reborn? Proposed “March In” Framework Unveiled By The Commerce Department

Pazdur As Book Critic: Big Sponsor/Small Sponsor Differences Are Clear To FDA Oncology Team, Director Declares In Discussion With Biotech Author

Prevision Policy Clips | FDA/Novartis Back-And-Forth On Kymriah Inspection Observations

Senate Finance Committee Zeroing In On Shortage Solutions: Hearing Highlights “Pay For Performance” And Targeted Manufacturing Investments As Potential Bipartisan Ideas

FDA “Digital Transformation” Entering More Visible And “Strategic” Stage, CIO Desai Says; Califf Warns That Siloed Approach In Government Remains A Threat To Overall Vision

Prevision Policy Clips | BIO Head Will Be Amicus CEO John Crowley

OTP Reorganization Has Increased Review Expertise In Specialty Disciplines, CBER Director Marks Says; “Live” Meeting Interactions Increasing Under Director Verdun

Prevision Policy Clips | FDA Vaccine Review Division Will Be Split In Two

Diversity In Clinical Trials: Early Planning To Include Underrepresented Populations Will Prevent Slowdowns In Drug Development, FDA’s Stein Says

Prevision Policy Clips | Clinical Trial Remuneration Could Increase Diversity Among Study Populations, FDA Office Of Medical Policy Deputy Director Karen Hicks

FDA “Diversity Plan” Analysis Shows Steep Learning Curve For Oncology Sponsors; Only Small Fraction Of OCE Submissions Were “Acceptable” In First Year

CMS Patient-Listening Sessions Disappoint: “Open Public Hearing” Approach Yields Little Useful Input; FDA PFDD Model Might Be Better

Prevision Policy Clips | AI In Drug Development: Clinical Trial Design And Conduct Are Potential Uses Of Artificial Intelligence

FDA Deputy Commissioner Will Be Chief Scientist Bumpus; Selection Assures Stability In Everyday Operations, Sets Succession Plan For Potential Biden Second Term

Prevision Policy Clips | FDA “Investigating” CAR-T Linked Malignancies; Affirms Positive Benefit-Risk Ratio

Prevision Policy Clips | On-Shoring Rx Manufacturing: HHS Plans $35 Million Investment

Advisory Committee Tracker: A Quiet End To A Busy Year

Prevision Policy Clips | FDA Oncology Chief Richard Pazdur, CBER Head Peter Marks Headline The 2024 Biopharma Congress On February 26

Prevision Policy Clips | HELP Committee Democrats Ask J&J, Bristol And Merck CEOs To Appear January 24

Prevision Policy Clips | After Makena: Preterm Birth Drug Development Meeting Hosted By FDA/Duke-Margolis Scheduled For January 23-24

Merck’s Gefapixant Rejected By FDA Panel: Large Placebo Response, Small Benefit Sink Chronic Cough Application Despite Relatively Clean Safety Profile

DTC “Major Statement” Rule Finalized At Last: FDA Acknowledges Change In Technology Since 2010 Proposal – But Says Principles Of “Clear, Conspicuous And Neutral” Still Apply

Prevision Policy Clips | Bad KarMMa? Bristol/2seventybio Abecma Label Expansion Heads To Advisory Committee, Review Extended

Prevision Policy Clips | End Of An Era: FDA Commissioner Califf To Name Successor “In The Future” To Principal Deputy Janet Woodcock Following Her Retirement In Early 2024