Prevision Policy Clips | Scholar Rock’s SMA Therapy Apitegromab Receives FDA CRL Due To Manufacturing Issues

FDA Safety Labeling Changes Guidance Update Adds “Reduced Effectiveness” As An Adverse Effect; New Draft Will Replace 2013 Final Guidance

Cell & Gene Therapy Sponsors Eager For More Guidance On “Platform” Approaches; OTP Listening Session Includes Ideas For “Platform Master Files,” “Joint BLAs”

Biosimilars Regulatory Standards “Update” Coming, CDER’s Tidmarsh Says; Future Model Will Be “Very Close To Generic Drugs”

Prevision Policy Clips | ACIP Tables Hepatitis B Vote; COVID Votes Appear Benign

Woodcock Unplugged: Ex-CDER Director Calls For New “Process Approval” Model For FDA, Warns Of “Backsliding” And “Circling The Wagons” In Review Teams

Prevision Policy Clips | FDA Senior Advisor To Commissioner Makary Is Former Enzyme CEO Jared Seehafer

Regulatory Approaches “Must Evolve” To Support Gene/Cell Therapies, OTP Acting Director Kumar Says; Leveraging Knowledge Across Programs Will Be Key Next Step

Prevision Policy Clips | VRBPAC Returns: 2026 Southern Flu Strain Selection Will Be One Topic Of October 9

Pediatric Exclusivity: Sponsors Push Back Against FDA’s Proposed Changes To BPCA/PREA; “Dual Leverage” Is Not “Double Dipping”

CDC Oversight Hearing Casts Shade On FDA: Kennedy Told Ousted Director That Other Agencies Were More Compliant; Hepatitis B Vaccine Newborn Use Is One Potential Change

Prevision Policy Clips | House GOP Continuing Resolution Includes OMUFA Reauthorization With Rx-To-OTC Switch Provisions

DTC Crackdown Starts With GLP-1s: Compounders, Lilly, Novo All Get Warning Letters; FDA Sends 40 “Untitled” Letters To Other Rx Firms

340B Program Increases Federal Costs, CBO Tells Congress, But Not Easy To Score; “Vertical Integration” Is Bigger Factor Than Contract Pharmacy In Growth, CBO Finds

Prevision Policy Clips | Pediatric Priority Review Voucher Reauthorization Set For Mark-Up

Prevision Policy Clips | RSV Vaccine Removed From ACIP Agenda; Votes Will Be Taken On COVID

CRL Statistics: Latest Batch Continues To Show Manufacturing/Quality Are More Common Reasons For FDA Rejections Than Clinical Issues

FDA CMC Readiness Pilot: Sponsors Report Positive Experiences Despite Limited Early Uptake

Prevision Policy Clips | AZ’s FluMist DTC Ad Draws Cease-And-Desist Letter Signed By CBER Director Prasad

MAHA Strategy Includes Drug Approval “Improvements”; Pediatric Cancer Treatment Plans Are AI Test Cases, While NIH Would Take RWD Platform Lead

Prevision Policy Clips | “Hybrid” Pre-Approval Inspections Final Guidance Provides Clarification On Timelines

Non-Opioid Analgesics For Chronic Pain: Broad Label Could Be Supported By Combining Condition-Specific Indications, FDA Guidance Suggests

Prevision Policy Clips | Non-Opioid Chronic Pain Guidance Recommendations Include Superiority Trial Designs

HHS Seeks To Close Down DTC Ads By Strengthening Disclosure Rules: FDA Starts Campaign With Broad “Notice” Letters And 100 “Cease And Desist” Warnings

Preserving Placebos In Rare Disease Trials: FDA Showcases Flexibility During First “RISE” Meeting – But Makes Case That Placebo Controls Still Have A Place