BIOSECURE Act Sets 2032 Deadline For Severing Ties With A “Company Of Concern” Under Revised Draft, Five-Year Compliance Period Added For Newly Identified Firms

Prevision Policy Clips | Platform Technology Guidance Awaiting OMB Clearance

A Peek Inside OCE: FDA Oncology Division Directors See Advantages Of Keeping Sponsor Meetings Virtual, Reflect On Leadership Amid COVID

Prevision Policy Clips | Strategic National Stockpile “Mismanagement”: House E&C Republicans Issue Letter

CBER Is “Neutral” On CAR-T Manufacturing Strategies, So Long As Quality Is Maintained, Director Marks Says; “Wave” Of Automation Could Bring Down Costs

Prevision Policy Clips | Moderna RSV Vaccine Review Delayed By “Administrative Constraints”; FDA Will Miss Deadline

Senate Drug Shortage Bill Would Create Medicare Shortage Mitigation Program; Generic Medicaid Inflation Rebate Changes, Add-On Payments Included

Prevision Policy Clips | Duke Margolis Drug Shortage Prevention Workshop June 12

Advisory Committee Voting Still A Hot Topic: Sen. Manchin Pushes Califf To Keep Votes During Budget Hearing; Avian Flu Is Growing Priority For FDA And Congress

Prevision Policy Clips | Pfizer “Pauses” Dosing In DMD Gene Therapy Trial After Patient Death

CDER International Post-Market CMC Review Pilot Bearing Fruit, Director Cavazzoni Says; Single Review Platform For All CDER Apps Coming Soon

Making Medicare Price Cuts Work: CMS Proposes “Standard” Refund Tied To WAC, But Manufacturers Must Allow For Actual Cost Agreements; 340B Pricing Adds Complexity

Prevision Policy Clips | Lykos MDMA (Midomafetamine) Advisory Committee Review Will Test Climate For Psychedelic Treatments

FDA Platform Technology Effort Occurring At Opportune Time: Gene Editing Advances May Allow FDA To Be More Ambitious With Pathway

Prevision Policy Clips | OCE “Project 5-In-5”: FDA Oncology Center “Crowdsourcing” Five Pragmatic Oncology Trial Ideas

Price Negotiation Year 2: Lower Prices And Fewer Meetings? CMS Draft Guidance Tweaks Price-Cutting Process In Anticipation Of More Drugs And Tighter Timelines

Prevision Policy Clips | Price Negotiation Year 2: Manufacturers Will Have Mid-December Deadline To Request Exemptions

Prevision Policy Clips | Schizophrenia Drug Development: FDA Meeting On Approaches To “Negative Symptoms”

Prevision Policy Clips | “Reshoring” Drug Production: DoD Pressed To Do More

FDA Advisory Committee “Listening Session”: Stakeholder Outreach Unlikely To Prompt Major Changes; Fighting Misperceptions Is One Theme

Advisory Committee Tracker: Novo Once-Weekly Insulin Will Head To Committee In May; Donanemab, Ocaliva Reviews In The Works

FDA Quantitative Medicine Center Aims To Move Drug Development Move Away From “Ad Hoc” Use Of Modeling And Simulation; OCP’s Madabushi Is First Director

FDA OCE Questions “Unnecessarily Restrictive Eligibility Criteria” With Three New Guidances On Lab Values, Washout Periods, And Performance Status

Prevision Policy Clips | Public “Persistent Misconception” Of FDA Advisory Committees One Topic For Discussion

LDT Final Rule Takes Lighter Touch: Existing Tests Will Be “Grandfathered” But Subject To More FDA Scrutiny; New Versions Will Be Subject To Pre-Market Review