FDA Offers “Streamlined” Distributed Manufacturing Facility Registration In Proposed Rule; Policy Is Intended To Further Promote Onshoring Efforts

PROMIS Oncology COA Qualification Demonstrates Complexity Of FDA Review, Long Road To Approved Use

Prevision Policy Clips | Acting FDA Commissioner Diamantas Highlights Advancing Health Security Among Future Priorities

Prevision Policy Clips | PDUFA Precursor: FDA Is Focus Of House Energy & Commerce Health Subcommittee Hearing July 15

ICER’s First Vaccine Review: Panel Endorses Long-Term Value Of COVID Vaccines But Says Not Enough Evidence To Distinguish Between Them

Prevision Policy Clips | FDA Grants Accelerated Approval To Vera’s Trutakna

Updated HHS Regulatory Agenda: Clinical Trials Rulemaking, DTC Advertising Restrictions And “Complete Response” Rule Planned For Remainder Of 2026

Prevision Policy Clips | CDER Acting Director For Clinical Science Is Lisa Yanoff; Former OCHEN Deputy Moves

FDA Returns To Pre-Pandemic Inspection Levels In FY 2025 With More Domestic Inspections And Use Of Mutual Recognition Agreements

Back To The Future: 340B Payment Cut Of ASP-33.4% Proposed By CMS, Policy Change Goes Deeper Than Trump I Reductions But These May Stick

Prevision Policy Clips | FDA Deputy CMO Mundkur Resigns, Signals Leadership Announcements May Be Getting Close

FDA Commissioner Office Revamp Under Consideration By HHS: Medical Products Head Would Oversee Centers; Pazdur Said To Be In The Running

Prevision Policy Clips | Vertex Casgevy Gene Therapy Is Eighth CNPV Approval; Sickle Cell Indication Expanded To Children Two Years And Up

FDA NME Approvals Running Ahead Of 2025 Pace; More NME Approvals So Far In 2026 Despite Continuing CRLs; July Off To A Good Start

Prevision Policy Clips | Acting CBER Director Karim Mikhail Will Serve As Acting OTP Director

Prevision Policy Clips | CBER’s OTP Director Vijay Kumar Steps Down, Acting Deputy Director Megha Kaushal Is Most Senior

Model-Based Dose Selection Guidance For Phase I Trials Focuses On Continued Refinement, Repeated Engagement With FDA

Prevision Policy Clips | July Heats Up: Replimune Melanoma Drug Will Go To ODAC In Late July

Prevision Policy Clips | Capricor’s DMD Drug Deramiocel Goes To FDA’s Cellular, Tissue, And Gene Therapies Advisory Committee July 29

Prevision Policy Clips | Prior Authorization Bills Included In House Energy & Commerce Health Subcommittee Markup

“Basket Trials” Added To FDA Draft Guidance On Master Protocols; Update Is Packaged As Part Of “TrialBlazer” Initiative As Agency Continues To Encourage Use Of MPs

Advisory Committee Tracker: FDA Promises More Meetings To Rare Disease Advocates, But Nothing On The Agenda; Will Makary-Era Reversals Go To Panel?

Prevision Policy Clips | FDA Commissioner Search: White House Policy Staffer Heidi Overton Is One Candidate

Oncology Center Of Excellence Under De Claro: 2025 Report Praises “Institutional Resilience” Of OCE, Includes Roster Of “Project” Leadership

“Act For ALS” Appears Primed For Reauthorization By Congress; “ALL ALS” Research Collaboration Keeping Issue Front And Center