Advancing Advanced Manufacturing: FDA Regulatory Framework Ready For Public Feedback, Launches “ETP 2.0” To Advise Sponsors

EUAs For Anti-Abuse Agents? FDA Hears Call For Urgency During Stimulant Use Disorder Treatment Workshop, But Stresses Need For Progress Before Updating Guidance

OPQ “Aligned Teams” Approach To Quality Reviews Now Functional For All Application Types: Smaller Groups Bring Greater Efficiency, FDA Says

Prevision Policy Clips | Biopharma Congress Virtual Series: Acting FDA Commissioner Woodcock, OCE Director Pazdur, CMS’ Jon Blum

FDA Investigators Say “Virtual” Inspections Are No Replacement For In-Person Visits – Literally Or Figuratively

Pfizer/BioNTech’s COVID Vaccine For Children: After A Brief Scare, VRBPAC Recommends Authorization; FDA Model Is Double-Edged Sword

Prevision Policy Clips | CDER Formally Names ElZarrad As Director Of Office Of Medical Policy

Prevision Policy Clips | FDA Oncology Accelerated Approval Trackers

Advisory Committee Tracker: COVID Keeping FDA Committees Busy; Merck/Ridgeback Antiviral EUA Is New Addition

Prevision Policy Clips | Oncopeptides' Pepaxto Pulled From Market After Multiple Myeloma Confirmatory Trial Fails; FDA Advisory Committee Canceled

Pfizer/BioNTech COVID Vaccine For 5-11 Year-Olds: Authorization Looks Certain, But Myocarditis Risk A Consideration Under Modeled Scenarios

Mandatory Prescriber Education For Opioids After All? FDA Exploring Upgraded REMS, But Urged To Go Beyond Making Existing Program A Requirement

Mix/Match Sets Groundwork For Positive ACIP Vote On Moderna, J&J Boosters; Myocarditis And TTS Concerns Remain For Younger Population

Prevision Policy Clips | Pfizer/BioNTech Vaccine Over 90% Effective In Children Under 12, Sponsor Briefing Document Says; Still Waiting On FDA

Real-World Data And FDA Standards: Agency Confident RWD Can Be Modified To Meet Electronic Submission Requirements – With Careful Documentation

Accelerated Approval And Rare Disease: EveryLife Event Showcases Projects That Could Benefit From New FDA/Industry Biomarker Projects; Advocates Ready To Defend AA – But Want It Used More

Prevision Policy Clips | COVID-19 Vaccine EUA Updates May Include Booster Expansion To Those As Young As 40 Years Old

Continuous Manufacturing Guidance: Therapeutic Protein Contamination Control Among Recommendations In FDA/ICH Guidelines

Prevision Policy Clips | The Power Of CMS? Biogen Reports Third Quarter Aduhelm Sales Of Just $300,000

FDA Workshop Addresses Neonatal Analgesic Trial Design And Conduct Challenges

Prevision Policy Clips | FDA Guidance Practices Would Revert To Pre-Trump Policies: HHS Proposes To Revoke Trump Administration Rule

Prevision Policy Clips | Interchangeable Humira To Launch In 2023: Boehringer-Ingelheim Adalimumab Copy Cyltezo

Mix/Match COVID-19 Vaccine Boosters Endorsed By FDA Committee For Practical Reasons; “General Language” On Mixing Doses Could Be Added To EUAs

“Second Dose For All” For J&J’s COVID-19 Vaccine Clears Committee; Follow Up Discussion May Lead To Broader Booster Range For Pfizer And Moderna

Prevision Policy Clips | FDA Commissioner Califf? “Not Quite,” White House Press Secretary Says