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Prevision Policy Clips | FDA Compounding Enforcement Starting Over – Again; MOU Withdrawn, New Rulemaking Will Begin
February 24, 2022
Unger Unplugged: FDA Needs Accelerated Approval To “Take More Chances” – But Also A Clear Path To Withdrawal, Ex-Office Director Says
February 23, 2022
Prevision Policy Clips | Continuous Direct Compression Manufacturing Process Is First “Graduate” Of FDA Emerging Technology Program
February 23, 2022
Prevision Policy Clips | Third Time’s A Charm? Mallinckrodt Terlipressin Receives Third Complete Response Letter From FDA
February 22, 2022
Prevision Policy Clips | Deadlock FTC Vote Means No PBM Study On How Business Practices Impact Drug Prices…For Now
February 18, 2022
Biosimilar First-Cycle Approvals Up Under BSUFA II; Oncologic And Hematologic Indications Lag Compared To Others
February 17, 2022
Prevision Policy Clips | ARPA-H Odds Of Landing Within NIH Increase With Naming Of Francis Collins As Science Advisor To President Biden
February 17, 2022
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
February 16, 2022
Prevision Policy Clips | Amylyx’ ALS Treatment AMX0035 Headed To FDA Advisory Committee March 30
February 16, 2022
Post-COVID FDA: Commissioner Califf’s First Priorities Of Improving Morale, Inspections Will Have To Be Balanced Against Political Promises
February 15, 2022
RWE Guidance On Regulatory Decision-Making: FDA Stresses Clarity On “Role” Of Evidence In Development Program, Fit-For-Purpose Data
February 15, 2022
Prevision Policy Clips | FDA Nominee Robert Califf Set To Clear Senate
February 15, 2022
Humira Biosimilar Competition Heads AAM Medicare Objectives; Clearing Inspection Backlog Also Priority For Generics/Biosimilars Industry
February 14, 2022
Prevision Policy Clips | Pfizer/BioNTech Pediatric COVID Vaccine Delayed Until At Least April
February 14, 2022
Avenue IV Tramadol Appeal Heads To FDA Committee: Outcome May Hinge On European Safety Experience
February 11, 2022
Prevision Policy Clips | FDA Nominee Califf Appears Set For Confirmation Vote In Senate
February 11, 2022
Lilly Plan To Disrupt Anti-PD1 Market Blows Up: Advisory Committee Rejection Of Sintilimab Suggests Damaged Relationship With FDA
February 10, 2022
Prevision Policy Clips | Accelerated Approval Confirmatory Trial Cleanup Coming, Califf Promises
February 10, 2022
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
February 9, 2022
ARPA-H Real-World Preview: House Hearing Addresses How Development Agency Would Fit Among Established Groups
February 9, 2022
Prevision Policy Clips | FDA Non-Opioid Acute Pain Guidance Includes Discussion Of “Opioid-Sparing” Effects
February 9, 2022
FDA Pilot Program On Unannounced Foreign Inspections Gets Another Push From GAO
February 9, 2022
Antibody-Drug Conjugate Complexity And Narrow Therapeutic Window Addressed In FDA Draft Guidance On Pharmacology Considerations
February 8, 2022
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
February 8, 2022
Prevision Policy Clips | ARPA-H House Hearing Will Go On Despite Resignation Of Biden Chief Science Advisor Eric Lander
February 8, 2022
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