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FDA Sets One-Day Goal For First Responses To COVID-19 Product Developers As Part Of “COVID-19 Treatment Acceleration Program”
March 31, 2020
Prevision Policy Clips | Janssen COVID-19 Vaccine Partnership With HHS Expands With Non-Profit Entity
March 31, 2020
Infected Trials II: FDA Specifies Challenges To Ongoing Studies In Update To COVID-19 Guidance
March 30, 2020
Shortage Notifications: FDA Direct-To-Final Guidance Asks For Reports For Any Anticipated Decline In Supply, Regardless Of Market Dynamics
March 30, 2020
FDA Formally Ends Clinical Data Summary Pilot, Recommends International Library Managed By Third Party
March 30, 2020
Clinical Trial Conduct During COVID-19 May Boost Use Of Digital Tools; Ex-FDA Head Califf Sees FDA Guidance As “Propulsive Force” For Digital Monitoring
March 30, 2020
FDA Chloroquine COVID-19 “Approval”: Tactical Response By FDA Matches Trump Rhetoric But Assures Feds Control Limited Supply
March 30, 2020
Prevision Policy Clips | FDA Chloroquine/Hydroxychloroquine COVID-19 “Approval” March 28
March 30, 2020
FDA’s COVID-19 Outlook: Missed User Fee Deadlines Unlikely, But Some Work Will Be “Set Aside”– An Interview With CDER Director Woodcock
March 27, 2020
Advisory Committee Tracker: FDA Clears Calendar; Most – But Not All – Cancellations Due To COVID-19
March 27, 2020
Prevision Policy Clips | MedPAC Working On “Alternate Arrangement” For April Meeting
March 27, 2020
FDA Real-World Research Focus Remains On Comparison Of RWE With Traditional Methods
March 27, 2020
Prevision Policy Clips | Intercept Ocaliva NASH Advisory Committee Date Pushed Back To June 9
March 26, 2020
OCE Communicates Drug Review Readiness: Commits To Continued Broad, Virtual Contacts And Maintaining Coordinated Reviews
March 26, 2020
Rx Supply Chain Reforms Stay In Final COVID-19 Response/Stimulus Bill; FDA Gets Immediate Boost Of $80 Million Plus Long-Sought OTC Monograph User Fees
March 25, 2020
Prevision Policy Clips | Part D Overhaul, Other Drug Pricing Measures Off The Table In Stimulus Deal
March 25, 2020
Prevision Policy Clips | No More FDA Panel Meetings In April: Medical Imaging Drugs Advisory Committee Is Postponed
March 24, 2020
FDA Will Follow Direct-To-Final Guidance Policy For COVID-19 Documents; Public Comment Will Be Considered Through Center-Wide Dockets
March 23, 2020
Prevision Policy Clips | Welcome To “Deeming Day”: NDA-to-BLA Transition Milestone Won’t Get Much Fanfare
March 23, 2020
COVID-19 Stimulus Package Likely To Include Changes To Shortage Reporting And Response Obligations; DISARM Antibiotic Incentive May Hitch A Ride
March 20, 2020
Virtual Advisory Committee Meetings And Phone-A-Friend: FDA Readies Panel-Like Interactions For Coming Months Of Distancing
March 20, 2020
Trump FDA-Day On COVID-19 Blends White House Cutting Red Tape With FDA Defense Of Data Collection; Gilead, Regeneron Projects Highlighted
March 20, 2020
Prevision Policy Clips | Adverse Event Reports During COVID-19: Pandemic Influenza Approach Applies, FDA Says
March 20, 2020
CDER-Led Task Force On “Rapid Development” Of COVID-19 Antivirals Recommended By Former FDA Commissioners
March 19, 2020
Prevision Policy Clips | FDA Suspends Domestic Inspections Amid COVID-19 Outbreak, Exploring Options To Fulfill Oversight Goals
March 19, 2020
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