Prevision Policy Clips | FDA Compounding Enforcement Starting Over – Again; MOU Withdrawn, New Rulemaking Will Begin

Unger Unplugged: FDA Needs Accelerated Approval To “Take More Chances” – But Also A Clear Path To Withdrawal, Ex-Office Director Says

Prevision Policy Clips | Continuous Direct Compression Manufacturing Process Is First “Graduate” Of FDA Emerging Technology Program

Prevision Policy Clips | Third Time’s A Charm? Mallinckrodt Terlipressin Receives Third Complete Response Letter From FDA

Prevision Policy Clips | Deadlock FTC Vote Means No PBM Study On How Business Practices Impact Drug Prices…For Now

Biosimilar First-Cycle Approvals Up Under BSUFA II; Oncologic And Hematologic Indications Lag Compared To Others

Prevision Policy Clips | ARPA-H Odds Of Landing Within NIH Increase With Naming Of Francis Collins As Science Advisor To President Biden

Avenue’s Road To Market Still Blocked For Tramadol IV After Advisory Committee Rejects Appeal; Vocal Minority Supports Access To New Option, But Risky For FDA To Listen

Prevision Policy Clips | Amylyx’ ALS Treatment AMX0035 Headed To FDA Advisory Committee March 30

Post-COVID FDA: Commissioner Califf’s First Priorities Of Improving Morale, Inspections Will Have To Be Balanced Against Political Promises

RWE Guidance On Regulatory Decision-Making: FDA Stresses Clarity On “Role” Of Evidence In Development Program, Fit-For-Purpose Data

Prevision Policy Clips | FDA Nominee Robert Califf Set To Clear Senate

Humira Biosimilar Competition Heads AAM Medicare Objectives; Clearing Inspection Backlog Also Priority For Generics/Biosimilars Industry

Prevision Policy Clips | Pfizer/BioNTech Pediatric COVID Vaccine Delayed Until At Least April

Avenue IV Tramadol Appeal Heads To FDA Committee: Outcome May Hinge On European Safety Experience

Prevision Policy Clips | FDA Nominee Califf Appears Set For Confirmation Vote In Senate

Lilly Plan To Disrupt Anti-PD1 Market Blows Up: Advisory Committee Rejection Of Sintilimab Suggests Damaged Relationship With FDA

Prevision Policy Clips | Accelerated Approval Confirmatory Trial Cleanup Coming, Califf Promises

FDA Acute Pain Drug Development Guidance Outlines Three “Opioid-Sparing” Claims – But Sets High Bar For Each; General Advice Unchanged From 2014 Draft, But Novel Mechanisms May Need More

ARPA-H Real-World Preview: House Hearing Addresses How Development Agency Would Fit Among Established Groups

Prevision Policy Clips | FDA Non-Opioid Acute Pain Guidance Includes Discussion Of “Opioid-Sparing” Effects

FDA Pilot Program On Unannounced Foreign Inspections Gets Another Push From GAO

Antibody-Drug Conjugate Complexity And Narrow Therapeutic Window Addressed In FDA Draft Guidance On Pharmacology Considerations

FDA Sintilimab Review Completes Public Re-Set On China-Only Trials: Lilly/Innovent ORIENT-11 Is Positive Study, Agency Says, But Inadequate For US Approval Of PD1 Inhibitor

Prevision Policy Clips | ARPA-H House Hearing Will Go On Despite Resignation Of Biden Chief Science Advisor Eric Lander