FNIH Ultra-Rare Cancer Drug Development Partnership Likely To Move Forward; FDA Agrees Time Is Right For New Model That Won’t Compete With Commercial R&D

Prevision Policy Clips | Kidney Transplant Drugs: FDA Workshop Will Focus On Pathways To Encourage More Tolerable Therapies

Prevision Policy Clips | Oncopeptides Pepaxto Withdrawal Formally Proposed By FDA: First Test Of New FDORA Pathway

FDA And “Three Spheres” Of Artificial Intelligence: Califf Sees Internal Benefits For Freeing Up Personnel, Predictive Modeling Requires Continuous Updates

Prevision Policy Clips | Intarcia Fight To Salvage Exenatide Combo Product NDA Will Go To Advisory Committee

Part D Co-Pay “Smoothing”: CMS Objects To Debit Card Model In Draft Guidance Implementing IRA Provision; Two-Part Guidance Is Reminder That There Are No Simple Changes In Part D

Prevision Policy Clips | Part D “Smooth” Co-Pay Guidance Will Be Issued In Two Parts, CMS Says

FDA Informed Consent Guidance Sticks To Themes Of Establishing Safeguards In Complex Research Populations But Gives IRBs Flexibility When “New Information” Arises

Prevision Policy Clips | Amgen Lumakras AA Conversion Application Will Provide ODAC Case Study For “Successful” PFS Trial With Adverse Survival

Biosimilar Supplement Applications: FDA Offers Details On New Review Categories Under BsUFA III

Prevision Policy Clips | Hydroxychloroquine, Ephedrine Fail To Make FDA 503B Bulk Drug List For Compounding By Outsourcing Facilities

Prevision Policy Clips | Labeling For Biosimilar And Interchangeable Products Draft Guidance Under Review At OMB

Prevision Policy Clips | AZ Warning Letter For Breztri Aerosphere Is First Issued By FDA Office of Prescription Drug Promotion In 2023

Prevision Policy Clips | US WorldMeds Eflornithine Neuroblastoma Relapse Prevention NDA Will Be Reviewed By ODAC On October 4

Prevision Policy Clips | CDER Net Hiring Far Outpacing CBER With 186 New Hires Compared To Only Three Net Gains

Postmarket Data Collection Guidance For Underrepresented Groups Provides Broad FDA Advice On Approaches; Real-World Data Among Options

Prevision Policy Clips | Value-Based Purchasing Agreements In ALS: “There’s No Leverage”

Prevision Policy Clips | Postmarket Data Collection Guidance On Underrepresented Populations Features “Mechanisms” By Which FDA Can Request Or Require Information

Sickle Cell Gene Therapies Continue ICER Positive Gene Therapy Reviews; Past Inequities Create Favorable Context For Price/Coverage

Prevision Policy Clips | Postapproval Pregnancy Safety Studies: FDA/Duke Margolis Workshop Sept. 18-19

QTc Labeling Draft Guidance For Non-Antiarrhythmic Drugs: “Reasonable Evidence” Of Causal Cardiac Events Should Result In Boxed Warning, FDA Says

Prevision Policy Clips | FDA Schedules Listening Session On Product Recalls For Sept 29

Prevision Policy Clips | Sage/Biogen Zurzuvae Split Decision By FDA Approves Post-Partum Depression

Prevision Policy Clips | AZ/Sanofi Beyfortus Enthusiastically Endorsed By ACIP, Despite Concern About Price

Office Of Therapeutic Products Director Verdun Is A CBER Veteran; Internal Candidate Chosen For High-Profile Post Overseeing Gene/Cell Therapy Reviews