Prevision Policy Clips | Pharmacy Compounding: FDA Will Not Enforce 5% Limit On Interstate Shipment

GSK Daprodustat Cardio Risk Versus ESAs Will Be Focus Of Advisory Committee Discussion; Safety Issues Mirror AstraZeneca’s Failed Roxadustat

Prevision Policy Clips | Makena Withdrawal Hearing Provides Fuel For Thought On Accelerated Approval Reform

CBER Status Report: Cell/Gene Therapy And Blood Products Work Getting Back “Toward Normal,” But Pandemic Strain Still Heavy On Vaccines, Director Marks Says

Prevision Policy Clips | Neurodegenerative Gene Therapy Development Final Guidance Has Few Changes

Novartis’ Alpelisib Rare Disease Indication Is An Early Milestone For RWE: FDA Describes Accelerated Approval Helped By Expanded Access

Makena Withdrawal Vote Underscores Accelerated Approval Integrity, But Process Suggests Fighting FDA Can Pay Off For Some Sponsors

Prevision Policy Clips | FDA Finalizes Multi-Endpoints Guidance

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Drug Development Should Involve An “Appropriate Spectrum” Of Cancer Types To Demonstrate Efficacy, FDA Says In Draft Guidance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Prevision Policy Clips | Tissue Agnostic Oncology Drug Development: FDA Draft Guidance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