FDA Inspection Update: 52 NDAs Currently Delayed Due To Delays In Site Visits, But Domestic Inspections Are Ramping Up Quickly; Foreign Inspections To Resume In February

Prevision Policy Clips | Registry Guidance Is Next Part Of FDA’s Roll-Out Of Real-World Evidence Policy

FDA’s Janet Woodcock Looks Back And Ahead: Innovation In Agency Operations Has Been Most Rewarding – And Is Central To Her Post-FDA Plans

Merck’s Molnupiravir For Coronavirus: FDA Panel EUA Recommendation For Non-Hospitalized Patients Seems Certain; Late Data On Efficacy Is Wild Card

Prevision Policy Clips | CBO Part D Out-of-Pocket Cap Would “Modestly Boost” Rx Use By Medicare Beneficiaries

Amgen/AZ Asthma Candidate Tezepelumab May Trigger Step Therapy In Moderate To Severe Asthma If Priced Too High, ICER Panel Suggests

Bladder Cancer Development: BCG Shortage Poses Challenges For Trials, But FDA Says It Can Be Flexible; Delaying Cystectomy Not Viewed As Viable Primary Endpoint In NMIBC

Prevision Policy Clips | FDA Domestic Inspection Activity In FY21 Exceeded “Base Case” Scenario

FDA’s Credibility At Stake: Early Communication Ahead Of Major Actions (COVID Boosters, Aduhelm) Could Counter Misinformation, Ex-FDAer Sharfstein Says

HHS Finalizes Price/Rebate Reporting Rule; Data May Provide Window Into Impact Of Negotiation – Or Trigger Renewed Pricing Push If Current Effort Fails

Prevision Policy Clips | FDA Temporarily Suspends Clozapine REMS Program Just Four Days After A Change

BsUFA Ride-Along Candidates Include Changes To First Interchangeable Exclusivity, “Bio-Better” Pathway; Labeling Carve-Out Is Issue For Biosimilar And Generic Sponsors

Prevision Policy Clips | House Price Negotiation Provisions Would Save $15 Billion Per Year Once Fully Phased In, CBO

Prevision Policy Clips | HHS Finalizes Drug Price And Rebate Reporting Rule

The Evolving Door? FDA Commissioner-Nominee Califf Slated To Return To Agency With Four Years Immersed In Big Data Giving Him Broader Perspective

GDUFA III Enhancements: Impact Will Depend On Uptake Of New Meeting Options, Speakers Suggest During Public Review Of FDA/Industry Agreement

Prevision Policy Clips | Pfizer COVID-19 Booster For All Adults? ACIP To Consider Recommendation For Third Shot

Cures 2.0 Introduced With New Section On Decentralized Trials; Few Changes From Discussion Draft

Oncology Center Of Excellence 2.0? Change In FDA Leadership May Present Opportunity To Grant Full Review Authority To OCE

Big Effects In Small Gene Therapy Trials Ideal, But Benefit On “Good Surrogates” May Be Okay, FDA’s Bryan Says; OTAT Readies For PDUFA VII

Prevision Policy Clips | ARPA-H Would Be Established Under Cures 2.0 Legislation

Gene Therapy AAV Safety Advisory Committee About Transparency, CBER OTAT Director Bryan Says; Capping Dose Not On The Table Yet

Prevision Policy Clips | Califf Back To FDA: White House Makes Nomination Official; Woodcock To Stay On Through Transition

“Project Optimus”: Oncology Dose-Finding Trials Should Aim For Useful Information, Not Statistical Significance, FDA Says; Sponsors See Benefits In Embracing Dose Optimization

FDA Digital Health Center Of Excellence Coordination Is Key Priority, Director Bakul Patel Says