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Prevision Policy Clips | FDA Moved “Very Quickly” On Convalescent Plasma COVID-19 Clinical Trials Okay And Access
April 10, 2020
A New World: Early Predictions On Sustained Impact Of Coronavirus On Biopharma Regulation And Reimbursement Policy
April 9, 2020
Prevision Policy Clips | First Generic Of Proventil HFA Approved By FDA Amid Demand Spike For Albuterol Inhalers
April 9, 2020
Insurers Unprepared Administratively To Handle Coming Wave Of Gene And Regenerative Medicine Therapies, BlueCross BlueShield Executive Says
April 8, 2020
Prevision Policy Clips | FDA Reminds Sponsors It Can (And Will) Waive Pre-Approval Inspection Requirements
April 8, 2020
FDA Review Division Differences: Oncology Really Is Fastest, GAO Says, But Timelines Reflect Expedited Pathways, Not Reviewer Productivity
April 7, 2020
Prevision Policy Clips | Part D Out-Of-Pocket Limit For 2021 Set At $6,550
April 7, 2020
COVID-19 Next Emergency Use Drugs Anticipated In Coming Weeks: Duke-Margolis Head McClellan Stresses Better Tracking, Coordination Among Trials
April 6, 2020
The New Part D: MedPAC Endorses 30% Manufacturer Discount As Final Formula For Re-Design Takes Shape Amid COVID-19 Outbreak
April 6, 2020
Prevision Policy Clips | MedPAC Formally Endorses Part D Re-Design: 30% Manufacturer Discount In Catastrophic Phase
April 6, 2020
Tech-Enabled Drug Development: Language Gap Between Regulators, Digital Equipment Developers May Be One Barrier To Adoption
April 3, 2020
Prevision Policy Clips | User Fee Workload Projections: FDA Announces Report On Options
April 3, 2020
Ranitidine Market Withdrawal Presages Guidance On Nitrosamine Impurities, Risk Assessment; Odd Ending For Former #1 Rx Product
April 2, 2020
Prevision Policy Clips | PCORI Funding Duke COVID-19 Registry And Controlled Trial On Chloroquine/Hydroxychloroquine
April 2, 2020
Prevision Policy Clips | Chloroquine/Hydroxychloroquine In Short Supply Due To “Significant Surge In Demand”
April 1, 2020
OTC Drug Overhaul Will Be Key Priority For FDA Post-COVID-19; Purge Of “Category II” Ingredients Set For September
March 31, 2020
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
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