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Prevision Policy Clips | Sarpeta Golodirsen Approval Follows Successful Appeal, New Neurology Office Launch
December 13, 2019
Prevision Policy Clips | Hahn, HR 3 Votes This Afternoon
December 12, 2019
FDA Core Outcome Assessment Program Will Test Whether Academic Developers Working With FDA Grants Can Cut Duplication in Assessment Tools
December 11, 2019
House Price “Negotiation” Would Cut Global Sales For New Launches By 19%, CBO Estimates; Inflation Penalty, Part D Cap Estimates May Matter More
December 11, 2019
NASH Liver Disease Receives High-Level FDA Attention At Duke-Margolis Meeting; Reviewers Ready To Engage On First-Ever Treatments
December 11, 2019
Horizon Teprotumumab Likely Headed To Approval; Advisory Committee Focus Will Be Uncertainty On Duration Of Effect and Adverse Events In Rare Eye Disease
December 11, 2019
Correvio Vernakalant No Closer To US Approval After Committee Rejection; Enthusiasm For Further Studies Diminishes During Discussion
December 11, 2019
Prevision Policy Clips | Senate Hahn Vote Today?
December 11, 2019
FDA’s Woodcock Masterclass Testimony Turns Negative GAO Report On Foreign Inspections Into Consensus For More Hiring Authorities At Oversight Hearing
December 10, 2019
Repurposing Off-Patent Drugs: Large-Scale Business Models Will Need Incentives From Congress; A Topic For PDUFA VII?
December 10, 2019
Prevision Policy Clips | Senate Takes Up OTC Monograph Bill Today
December 10, 2019
Drug Pricing Update: Senate HELP Competition/Price Justification Bill Ready To Move At Year End; Finance Bill Still Waiting In The Wings While HR 3 Heads To Show Vote
December 9, 2019
Prevision Policy Clips | Bristol/Acceleron Reblozyl Won’t Go To ODAC After All
December 9, 2019
FDA After Woodcock: OND Reorg Not Prompting Retirements Yet, But The Time Will Come
December 6, 2019
FDA Earmarked For $2 Billion Boost From Price “Negotiation” Savings In HR 3; Summary Suggests Congressional Priorities For PDUFA VII Process
December 6, 2019
Correvio Vernakalant For Afib: Sponsor Hoping To Go From Clinical Hold Straight To Approval; FDA Review Suggests Another Rejection Coming
December 6, 2019
Prevision Policy Clips | House Majority Drug Bill (HR 3) Redistribution Of Drug Expenditure Savings
December 6, 2019
Choose Your Own Endpoint: FDA Interstitial Cystitis/Bladder Pain Syndrome Guidance Recommends Patients Self-Identify Symptom Endpoints
December 5, 2019
Prevision Policy Clips | Opioids Return to Advisory Committees
December 5, 2019
FDA Excipient Review Pilot Could De-Risk Development of Novel Ingredients; Agency Wants Feedback on Idea
December 4, 2019
Prevision Policy Clips | White House Claims HR 3 Impact On R&D Would Offset Savings
December 4, 2019
PDUFA VII: What’s On The Table For The Next FDA User Fee Reauthorization?
December 3, 2019
Antibiotic Labels: Could “Limited Use” Open Up To More Flexible Standards? FDA/IDSA Workshop Highlights Desire For Ways To Communicate Emerging Data
December 3, 2019
FDA Commissioner Nominee Hahn Clears Committee Hurdle, Looks Headed To Confirmation By Full Senate
December 3, 2019
Prevision Policy Clips | “Bespoke” Therapies CBER Workshop March 3:
December 3, 2019
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