CBER Readying For Packed Gene Therapy Calendar This Fall: Asks Sponsors To Keep In Touch About COVID-19 Trial Issues, Staffs Up Ahead Of Crush

Prevision Policy Clips | BARDA Leadership Shuffle Adds To Challenges Of Crisis Collaboration

Real-World Evidence Effort At FDA Ramps Up Amid COVID Response; Plaquenil Plays Pivotal Role

COVID Collaborations: “ACTIV” Aims For Near-Term Therapies, But Long-Term Implications Could Shape Future Of Public-Private Models

Prevision Policy Clips | FDA Planning Guidance On COVID-19 Product Development

Prevision Policy Clips | Seattle Genetics’ Tukysa Is First NME Approved Under OCE “Project Orbis”

ICER Patient Engagement Seeks More PRO/RWE Data; Looking To Turn Patient Advocates From Critics Of Cost Effectiveness Reviews Into Allies

FDA Advice On Remote Data Collection During COVID: Consistency Is Key, And May Not Always Be Possible; Bottleneck Likely In Seeking Input From Divisions

Prevision Policy Clips | FDA Updates Clinical Trials Guidance Again; Clinician-Reported And Performance Outcome Assessments May Not All Be Feasible Remotely

NDAs At Risk Of Delay? Oncology, Neurology Have Most Near-Term Deadlines At FDA, But Lower-Priority Applications At Higher Risk Amid COVID Disruptions

Prevision Policy Clips | NIH Trial Balloon For COVID Trials

Global Regulatory Convergence Urged For Regenerative Medicine; BioMarin Policy Head Proposes Topics For FDA Attention

NCI Accelerating Access To Genentech’s Actemra For Cancer Patients With COVID-19 Through “Treatment Referral” Program

Prevision Policy Clips | CMS Plan For Additional COVID-19 Related Policy/Regulatory Revisions Under OMB Review

FDA MyStudies App Could Be Starting Point For Gathering Post-Market Patient Perspective On Approved Drugs, UnitedHealth’s Okun Suggests

Prevision Policy Clips | FDA Extends Deadline For RWE Funding Opportunity

Changes in Cancer Trials: NCI Adjusting To Sharp Drop In Accruals; Predicts Short-Term Flexibility May Have Long-Term Impact

FDA Coronavirus Response Effort Starts With Three-Step Triage Process, OND Director Stein Says; Agency Response To Pandemic Is “Unprecedented”

Prevision Policy Clips | FDA’s Pazdur Sends A Message With New Drug Approval – Literally

FDA Update On Inspections During COVID Likely Coming Soon; CBER Operating Status Mirrors CDER’s At This Point In Outbreak

FDA Virtual Advisory Committees Are Coming, Stein Says: Meetings Will Require More Planning, Be Smaller And Focus On Specific Issues

Prevision Policy Clips | FDA Moved “Very Quickly” On Convalescent Plasma COVID-19 Clinical Trials Okay And Access

A New World: Early Predictions On Sustained Impact Of Coronavirus On Biopharma Regulation And Reimbursement Policy

Prevision Policy Clips | First Generic Of Proventil HFA Approved By FDA Amid Demand Spike For Albuterol Inhalers

Insurers Unprepared Administratively To Handle Coming Wave Of Gene And Regenerative Medicine Therapies, BlueCross BlueShield Executive Says