FDA Vaccines Advisory Committee Primed For COVID Emergency Use Applications: Members Reassured Of “Relatively High Standard” Prior To Candidate Reviews

Prevision Policy Clips | FDA’s COVID Vaccine Committee Meeting Paves Way For Product-Specific EUA Reviews

Purdue OxyContin Settlement: The End Of Efforts To Control Opioid Abuse By FDA Regulation; Trigger To Re-Think REMS?

Complex Generic Development: Drug Delivery Systems And User Interfaces Will Be Key Challenges Ahead, FDA’s Lionberger Predicts

Prevision Policy Clips | Purdue Opioid Settlement Includes Guilty Plea To FD&C Act Violation

Sentinel Helps FDA Connect To Big-Data/Tech Sector, Can Help Outside Developers As “Sage Advisor,” FDA’s Abernethy Tells Annual Workshop

Prevision Policy Clips | GAO May Investigate Claims Of Political Interference At FDA And CDC, But Not Until January

Prevision Policy Clips | BARDA COVID Vaccine Development Activities On Agenda For FDA Vaccines Advisory Committee

Prevision Policy Clips | Reagan-Udall Foundation Conducting Vaccine Confidence Listening Sessions

FDA Inspection Flexibility May Continue After COVID, CDER Director Says; Virtual AdComms May Be Here To Stay

CDER Has “Turned The Corner” On Hiring, Director Cavazzoni Says; COVID Strain Is Masking Gains In Staffing Thanks To Cures Authority

Inhaled Antifungal Products Are At Early Stage With Regulators: FDA Sees Opportunity To Define Clinical Endpoints, Address Diverse Patient Populations

Prevision Policy Clips | COVID-19 Vaccine Timeline: No October Surprise From Pfizer

FDA Quality Management Maturity Pilot Program Launched: US Finished-Dose Firms, Foreign API Sites Can Volunteer To Help Shape Metrics

Operation Warp Speed COVID Clinical Trial “Portal” Coming Soon, FDA’s Woodcock Says; View From “Other Side” May Help Refine Master Protocols

Prevision Policy Clips | AMAG/Covis Will Fight To Save Makena, CDER Launches Quality Manufacturing Pilot

Prevision Policy Clips | PDUFA Negotiations Continue

Prevision Policy Clips | CBER's Marks To Discuss Center Priorities At Biopharma Congress

Alkermes Olanzapine/Samidorphan Combo Gets Three Strong Positive Votes From FDA Committees: Smaller Girth Gains Are Convincing

Prevision Policy Clips | FDA Could "Add a Day" To COVID-19 Vaccine Advisory Committee Agenda For Sponsor Data

Time For “Independent FDA”? COVID-19 Political Pressure Reignites Debate

Arbor A Victim Of Climate Change: ADF Stimulant Voted Down By Joint FDA Advisory Committee As Opioid Real-World Experience Influences Panel Debate

Alkermes Olanzapine/Samidorphan Combo Poses Atypical Challenges For FDA Committee: Does Less Weight Gain Offset Potential Opioid Events?

FDA PFDD Meeting On Stimulant Use Disorder Shows Drugs Are Not Interchangeable Among Patients, Spotlights COVID Impact On Those In Recovery

Prevision Policy Clips | Biopharma Congress Features FDA Drug Review Leaders, Johns Hopkins' Sharfstein, ICER's Pearson