FDA’s COVID-19 Outlook: Missed User Fee Deadlines Unlikely, But Some Work Will Be “Set Aside”– An Interview With CDER Director Woodcock

Advisory Committee Tracker: FDA Clears Calendar; Most – But Not All – Cancellations Due To COVID-19

Prevision Policy Clips | MedPAC Working On “Alternate Arrangement” For April Meeting

FDA Real-World Research Focus Remains On Comparison Of RWE With Traditional Methods

Prevision Policy Clips | Intercept Ocaliva NASH Advisory Committee Date Pushed Back To June 9

OCE Communicates Drug Review Readiness: Commits To Continued Broad, Virtual Contacts And Maintaining Coordinated Reviews

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

Prevision Policy Clips | Part D Overhaul, Other Drug Pricing Measures Off The Table In Stimulus Deal

Prevision Policy Clips | No More FDA Panel Meetings In April: Medical Imaging Drugs Advisory Committee Is Postponed

FDA Will Follow Direct-To-Final Guidance Policy For COVID-19 Documents; Public Comment Will Be Considered Through Center-Wide Dockets

Prevision Policy Clips | Welcome To “Deeming Day”: NDA-to-BLA Transition Milestone Won’t Get Much Fanfare

COVID-19 Stimulus Package Likely To Include Changes To Shortage Reporting And Response Obligations; DISARM Antibiotic Incentive May Hitch A Ride

Virtual Advisory Committee Meetings And Phone-A-Friend: FDA Readies Panel-Like Interactions For Coming Months Of Distancing

Trump FDA-Day On COVID-19 Blends White House Cutting Red Tape With FDA Defense Of Data Collection; Gilead, Regeneron Projects Highlighted

Prevision Policy Clips | Adverse Event Reports During COVID-19: Pandemic Influenza Approach Applies, FDA Says

CDER-Led Task Force On “Rapid Development” Of COVID-19 Antivirals Recommended By Former FDA Commissioners

Prevision Policy Clips | FDA Suspends Domestic Inspections Amid COVID-19 Outbreak, Exploring Options To Fulfill Oversight Goals

Infected Trials: FDA Allows Flexibility In Clinical Trial Assessments From COVID-19, Ultimately Setting Different Review Expectations

Prevision Policy Clips | President Trump To Announce FDA Developments On COVID-19

OND Re-Org Enters Final Phase: New Faces In FDA Division Director Line Up Include Donohue (Rare Disease), Toerner (Hepatology), And Nikolov (Rheumatology)

Prevision Policy Clips | OND Re-org: Final Phase Begins March 15

Part D Redesign: CBO Sees Net Increase In Spending On Drug Benefit In Updated Senate Bill, Driven By Price Concession Pass Through; Inflation Penalty Still Drives Savings Overall

Prevision Policy Clips | FDA Drug Center Doing "Everything Possible" To Keep Reviews On Schedule, But Acknowledges Uncertainty

CMS Says Reduced Or No Cost-Sharing In Emergency COVID-19 Response Would “Satisfy” Anti-Kickback Safe Harbor

Prevision Policy Clips | "Competitive Generic Therapies" Do Not Automatically Get Expedited Review, Final FDA Guidance

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