Weighing “Weight Of The Evidence”: FDA Sees “Underbaked” Justifications From Sponsors Seeking To Streamline Preclinical Development; FOCR Framework May Help

Start Small? Accelerating Trial Starts May Involve Submitting Simpler Protocols, OCE Deputy Says; FDA First-In-Human Cancer Trials Guidance Will Help Internal Consistency

OCE To Have “Tremendous Leadership Role” In “Project TrialBlazer”; FDA Hoping To Make Expedited IND Pilot The “New Normal”

Prevision Policy Clips | FDA Nominee Overton Confirmation Vote In HELP Set For November 18; Cassidy Still “Undecided”

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Prevision Policy Clips | FDA Draft Guidance On Early-Phase IND Submissions For Solid Tumors Released Nov. 10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