Generic Drug Competition/Patent Bills Still Have Bipartisan Backing In The Senate; Product “Hopping” And “Sham” Petitions Are Not Unanimous In Judiciary Committee Mark-Up

FDA Cuts May Impact Complex Generic Reviews, Inspections Despite Intent To Keep Applications Moving, Former Commissioner Gottlieb Says

Prevision Policy Clips | Novavax COVID Vaccine BLA Poses Early “Test” For Commissioner Martin Makary

Makary Introduces Himself To FDA Staff: “Our Country Needs You…I Will Do My Best” To Assure Resources; COVID Response Critic Hoeg Joins As Special Advisor

MAHA Vision For FDA Includes New Pathways For “Root-Cause” Treatments, But Not Traditional Big Pharma; HHS Advisor Means Says Layoffs Reflect “Failure” Of Agencies

FDA Deadline Tracker: Still No Signs Of Slippage On User Fee Goal Dates – But Now The RIFs Are Here

Prevision Policy Clips | FDA After The RIFs: Reorganization Plan With Center Consolidation Likely

House E&C Oversight Of FDA Will Continue, Rep. Guthrie Pledges; OTC Drug Hearing Provides Opportunity For Democrats To Protest FDA Staff Layoffs

FDA Cuts Hit Hard; CBER Acting Director Is Scott Steele After Tierney Departs; OND’s Stein Is Another Leadership Loss; Biggest Impact May Be “Deleted” Divisions/Offices

Prevision Policy Clips | LDT Final Rule Vacated: Federal Court Rules FDA Lacks Authority To Regulate Lab-Developed Tests

Advisory Committee Tracker: Opioid Meeting Rescheduled For Early May, Set To Be First Advisory Committee Of The RFK/Makary Era

Prevision Policy Clips | Makary Era At FDA Faces Tough Beginning: Marks’ Resignation, 3,500 Job Cuts Pending

FDA Disruption Accelerates: CBER’s Marks Resigns, Citing Vaccine Safety Disputes And Putting Gene Therapy Progress At Risk; Who Will Lead Product Reviews Under Makary?

FDA Guidance Could Be Key To Encouraging Studies Of “Indirect Benefits” From Infectious Disease Treatments; Regulatory, Payment Policy Could Help Uptake, Margolis Authors Suggest

Prevision Policy Clips | FDA Oncology Center Of Excellence Losing Top Deputies: Paul Kluetz And Marc Theoret

Career Staff Changes At FDA: Drug Review Division Deputies Left Or Moved In Early Months Of Trump II

FDA “Mission Is Unchanged,” Acting Commissioner Brenner Assures Staff; “Radical” Changes Coming, But Agency Will “Eventually” Be In “A Much Stronger Place”

FDA Facing Deep Job Cuts To Non-Review Functions Under HHS Reorganization Plan; IT, HR, Procurement, Comms – And Policy – Will Be Centralized At Department Level

Prevision Policy Clips | FDA Faces 3,500 Job Cuts In HHS Reorganization Plan, But Reviewers/Inspectors Will Be Spared

Prevision Policy Clips | The Makary Era At FDA Begins: Senate Confirms Martin Makary As FDA Commissioner

Prevision Policy Clips | FDA Deputy Commissioner For Operations/COO Is DoD Veteran Barclay Butler

Prevision Policy Clips | White Oak U-Turn: Senate HELP General Counsel Barrett Tenbarge To Remain With Committee, No Longer Headed To FDA

A Glow Up For VAERS? Rebranding Vaccine Safety Systems With More Robust, Community-Level Data Could Address Vaccine Hesitancy, Gottlieb Says

Prevision Policy Clips | “Most Favored Nation” Drug Pricing Options Outlined By GOP Think Tank

Vaccine Uptake Depends On “Compelling Evidence,” Not “Mandates,” FDA’s Marks Says; Planning Ahead May Make It Easier To Measure Indirect Benefits To Encourage Adoption