CDER ARC Rare Disease Program Takes Shape; CBER Plans “Warp Speed”-Style Pilot In “Coming Year”

White House Biodefense Strategy Update Sees Limited Role For FDA But Ambitious Goals For Developing Vaccines And Therapeutics In Future Pandemics

FDA “Advancing Real-World Evidence” Program Offers Early Feedback On RWE Plans To Support New Indications; Disclosure Agreement Is Required

Cancer Immunotherapy Sponsors Should Prospectively Assess Immune-Mediated Reactions In Clinical Trials, FDA Says; Broad Net Needed To Catch Adverse Events

Nanotech Medicine Has Arrived At FDA: CDER Has Approved 77 Nanomaterial Products, CBER Work Includes mRNA Covid Vaccines

Prevision Policy Clips | PDUFA VII Implementation Continues: FDA Announces Advancing RWE & Complex Innovative Design Programs

Tissue Agnostic Oncology Drug Development Should Involve An “Appropriate Spectrum” Of Cancer Types To Demonstrate Efficacy, FDA Says In Draft Guidance

Prevision Policy Clips | Makena Withdrawal Hearing Day One: CDER Presents Uniform, Highly Disciplined Array Of Negative Assessments

Rare Disease Drug Development: “Multicomponent Endpoints” May Be Potential Solution For Enrolling Heterogenous Populations, FDA’s Donohue Says

Prevision Policy Clips | Tissue Agnostic Oncology Drug Development: FDA Draft Guidance

Part B May Be Focus Of Administrative Action On Drug Prices In 2023; Biden Executive Order Directs HHS To “Consider” Models That “Complement” IRA

Prevision Policy Clips | More To Come On Drug Pricing? Biden Signs Executive Order Oct. 14

Facility Inspections, Product Control Strategies Are Key Issues For “Decentralized” Manufacturing Strategies, FDA Suggests In Discussion Paper

Prevision Policy Clips | CMS Formally Establishes Drug Price Negotiation Team

FDA/MITRE REMS Integration Pilot Is Launch-Ready: Stakeholders Are Enthusiastic But Wary Given Disruptive Transition With Clozapine, Isotretinoin

Prevision Policy Clips | CBER Received 30 RMAT Requests In FY 2022

FDA Clinical Decision Support Software Final Guidance Clarifies Criteria For Non-Device CDS, Steps Away From International Forum Risk Categories

Prevision Policy Clips | BIO Makes Leadership Change: Former GlycoMimetics CEO Rachel King Named Interim Head

Prevision Policy Clips | CDER Emphasizes Case For Makena Withdrawal In Briefing Document

Gene Therapy And Accelerated Approval: Skysona Review Memo Suggests Bluebird Experience Is Important Precedent – But Not Easy To Follow

Prevision Policy Clips | GDUFA III Guidances Continue To Roll Out: FDA Updates Competitive Generics, Post CRL Teleconference Guidances

MedPAC Focus On Part D Going Forward: Keeping A Close Eye On Rebates As Inflation Reduction Act Is Implemented

The New User Fees: NDA/ANDA Filing Fees Grow Modestly In FY 2023, But Biosimilar Fees Stay Flat

Prevision Policy Clips | Cardio-Renal Advisory Committee To Meet Dec. 13-14 To Review Cytokinetics Heart Failure Drug, Viatris’ Pediatric Revatio

CBER Office Of Therapeutic Products Re-Org Takes Effect In February 2023; Hiring For New Positions Is Underway