Prevision Policy Clips | FDA Reminds Sponsors It Can (And Will) Waive Pre-Approval Inspection Requirements

FDA Review Division Differences: Oncology Really Is Fastest, GAO Says, But Timelines Reflect Expedited Pathways, Not Reviewer Productivity

Prevision Policy Clips | Part D Out-Of-Pocket Limit For 2021 Set At $6,550

COVID-19 Next Emergency Use Drugs Anticipated In Coming Weeks: Duke-Margolis Head McClellan Stresses Better Tracking, Coordination Among Trials

The New Part D: MedPAC Endorses 30% Manufacturer Discount As Final Formula For Re-Design Takes Shape Amid COVID-19 Outbreak

Prevision Policy Clips | MedPAC Formally Endorses Part D Re-Design: 30% Manufacturer Discount In Catastrophic Phase

Tech-Enabled Drug Development: Language Gap Between Regulators, Digital Equipment Developers May Be One Barrier To Adoption

Prevision Policy Clips | User Fee Workload Projections: FDA Announces Report On Options

Ranitidine Market Withdrawal Presages Guidance On Nitrosamine Impurities, Risk Assessment; Odd Ending For Former #1 Rx Product

Prevision Policy Clips | PCORI Funding Duke COVID-19 Registry And Controlled Trial On Chloroquine/Hydroxychloroquine

Prevision Policy Clips | Chloroquine/Hydroxychloroquine In Short Supply Due To “Significant Surge In Demand”

OTC Drug Overhaul Will Be Key Priority For FDA Post-COVID-19; Purge Of “Category II” Ingredients Set For September

FDA Sets One-Day Goal For First Responses To COVID-19 Product Developers As Part Of “COVID-19 Treatment Acceleration Program”

Prevision Policy Clips | Janssen COVID-19 Vaccine Partnership With HHS Expands With Non-Profit Entity

Infected Trials II: FDA Specifies Challenges To Ongoing Studies In Update To COVID-19 Guidance

Shortage Notifications: FDA Direct-To-Final Guidance Asks For Reports For Any Anticipated Decline In Supply, Regardless Of Market Dynamics

FDA Formally Ends Clinical Data Summary Pilot, Recommends International Library Managed By Third Party

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

FDA Chloroquine COVID-19 “Approval”: Tactical Response By FDA Matches Trump Rhetoric But Assures Feds Control Limited Supply

Prevision Policy Clips | FDA Chloroquine/Hydroxychloroquine COVID-19 “Approval” March 28

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