BIO PDUFA VIII Wish List: “BioAdvance” Plan Leans Into America First Themes, Calls For Faster Path to First-in-Human Clinical Studies, “Fit For Purpose” FDA Evidence Standards

FDA Seeks Input On Patient-Level Data Access For RWE; Timelines Suggest Guidance For Use In Drug Reviews May Be Delayed

FDA Commissioner Nominee Overton Will Receive Senate HELP Confirmation Vote Nov. 18

Prevision Policy Clips | FDA Draft Guidance On Early-Phase IND Submissions For Solid Tumors Released Nov. 10

Novel Antihypertensive Class Panned By ICER Panel: “ASIs” May Risk Replay Of PCSK9s With High Prices And No Outcomes Data; Should Regulatory Bar Be Higher?

No Turning Back: CMS Final Rule On Medicare Price Negotiation Closes Biologics SubQ “Loophole,” Keeps Approach To Gene Therapy Price Calculation

Prevision Policy Clips | Expedited IND Pilot Exceeds 100 Requests To Participate, FDA Says

Prevision Policy Clips | CMS Medicare Price Negotiation Final Rule: SubQ Biologics Formulations Will Not Qualify As New Products

Prevision Policy Clips | House Leadership Moves Take Shape: Pallone, Neal Expected To Reclaim Energy & Commerce, Ways & Means Gavels

Prevision Policy Clips | FDA, Rx Industry Prepare For Democratic Oversight

Small Molecules, Big Price Tags: ICER Finds Doubling In Launch Prices For Novel Small Molecule Drugs Between 2022-2025; Reaction To IRA?

Deadline Tracker: November Approvals Could Bring FDA Near Record For NMEs; Etcamah, Lyrfigtu Approvals Showcase Different Themes For Accelerated Approvals In Oncology

Prevision Policy Clips | Drug Facility Listing Removal Process Streamlined By FDA

FDA Sticks To Cell & Gene Therapy Potency Assurance Recommendations In Final Guidance, Provides Case Examples To Help Guide Sponsors

Sydnexis Ophthalmic Atropine Appeal: Advisory Committee Sides With FDA On Issues With Evidence Of Efficacy; Compounding Use Not Relevant To Discussion, Agency Says

Prevision Policy Clips | UniQure Huntington’s Gene Therapy BLA Expected To Go To Advisory Committee

FDA Drug Inspection Operations Update Features More Involvement Of Drug Center; ConOps 2.0 Revision Includes Remote Regulatory Assessments

Prevision Policy Clips | CDER Associate Director For Research Is Scott Steele

Advisory Committee Tracker: Biohaven’s Troriluzole Will Be Next Reconsideration Of Makary-Era Rejection To Go To Committee; Date TBD

HELP Leadership Change In 2027 Will Complicate User Fee Reauthorization, Staffer Warns; Clinical Trial Reform, Country-of-Origin Labeling Measures Are Likely PDUFA Riders

Rare Disease Framework Needs Top-To-Bottom Implementation, Patient Advocates Tell FDA; Structural Changes For Review Teams Suggested

Prevision Policy Clips | FDA “Single Trial” Policy Change Explains “Full” Approval For Lyrfigtu

HHS Interim Policy Opens Up Market To Compound Six Peptides That Received Positive Votes At July PCAC: FDA Objections Overruled; Guardrails Include Ban On Combos, Complex Dosage Forms

“Now Is The Moment For Us To Step In”: FDA Center Directors Explain Drivers For Rare Disease Framework, Key Goals For Early Implementation

Sydnexis Atropine Ophthalmic Appeal Will Showcase New Era For Advisory Committees; FDA Has Long List Of Efficacy Concerns, And Is Not Asking For A Vote