Prevision Policy Clips | CDER Approved 90 First Generics In 2023: Office Of Generic Drugs Annual Report

Rare Disease Regulatory Consistency: CBER’s Marks Predicts Greater Harmony In FDA Advice In Near Future During MPS Meeting; Biologics as Lead Center?

ICER Review Of Novartis And AstraZeneca PNH Therapies: Patient Adherence Will Be Critical Issue For Uptake Of Novel Oral Treatments, Panel Says

Prevision Policy Clips | Biopharma Congress Is Sold Out

Gene Therapy International Cooperation: FDA Hopes Simultaneous Reviews By Key Regulatory Bodies Will Make Some Rare Disease Markets More Viable

Diversity Action Plan Guidance Delayed As FDA Works To “Provide More Information”; OTP’s Fashoyin-Aje Says FDA Interprets Diversity “Very Broadly”

Prevision Policy Clips | FDA Updates COVID Therapeutics Development Guidance: New Version

Prevision Policy Clips | Iovance Amtagvi (Lifileucel) Melanoma Approval Is “First Tumor-Derived T-Cell Immunotherapy”

Implementing “Project Optimus”: Oncology Dose Optimization Can Learn From Other Areas – But Cancer Will Still Be Different; AACR Workshop Drills Down On Approaches

Prevision Policy Clips | Part D Co-Pay “Smoothing”: CMS Releases Second Implementation Guidance, Focusing On Pharmacy Outreach

CBER Readying For Next COVID Vaccine Strain Selection, Director Marks Says During House Hearing On Vaccine Safety Systems

Wholesaler/GPO Role In Drug Shortages Is New Focus For HHS/FTC Competition Initiative; RFI Asks About Impact Of Consolidation, Contracting On Supply Chain

Prevision Policy Clips | The New Accelerated Approval Withdrawal Process: “Stay Tuned…In Coming Weeks,” FDA’s Marks

Prevision Policy Clips | FDA Finalizes Updated Guidance On Charging For Investigational Drugs

Artificial Intelligence Getting Cross-Center Attention At FDA With AI Guidance Among Activities Under White House Executive Order; Can Trials Move From “Reactive To Predictive”?

“Adaptation Committee” Suggested By FDA As Tool For Adaptive Trial Oversight In Proposed Update To 2006 Guidance On Data Monitoring Committees

Prevision Policy Clips | “OCE Reunion” Panel At Biopharma Congress Feb. 26 Has Director Rick Pazdur Moderating

Psychedelics are “Sizeable Chunk” Of FDA Division of Psychiatry Workload; Teasing Out Role and Effect of Psychotherapy in Psychedelic Treatment Paradigm is a Key Issue

Prevision Policy Clips | Data Monitoring Committees Guidance: FDA Maintains Recommendations For A Charter Detailing Obligations, Responsibilities, And Procedures

Prevision Policy Clips | Diversity Action Plans Guidance: FDA “Actively Working” On Draft

Senate “Show Trial” On Drug Pricing Allows CEOs To Pitch Co-Pay And Contracting Reform Agenda; Medicare Negotiation Hangs Over Event – But Details Not Discussed

The War On Drug Shortages? Onshoring Push Would Start With Battlefield Medicines Under House Bill Discussed During Ways & Means Hearing; “Buffer Stocks” Also Have Support

Building Quality By Design In Clinical Trials Starts With Predicting What Can Go Wrong, FDA’s Stein Says; Natural History, Diversity Key Factors In Rare Diseases

Prevision Policy Clips | FDA’s VRBPAC To Review Flu Strains For Vaccines On March 5

Bespoke Gene Therapy Consortium “Playbook” For AAV Gene Therapy Development Published; “Platform-Approach” Could Be Model For New Pathway