COVID-19 Vaccines: Experience From Ebola, Previous Production Expansions Suggest Tough Challenges Ahead; Danger Of “Over-Promising”?

Prevision Policy Clips | FDA Approves Less-Frequent Dosing For Merck’s Keytruda Amid COVID-19 Disruptions

Advisory Committee Tracker: Preparing For Virtual Reality – Which Sponsor Will Go First?

Prevision Policy Clips | FDA Data Strategy Public Meeting Rescheduled For June 30

Prevision Policy Clips | HHS Secretary Azar Not Being Fired, President Trump Tweets

Rare Disease Clinical Trial Issues Heightened By COVID But Potential Exists for Long-Term Improvements With Remote Monitoring As CMS Loosens Some Technical Restrictions, Advocates Say

Prevision Policy Clips | HHS Infighting Casts Large Shadow Over COVID-19 Response

FDA Guidance On COVID-19 Trials Likely To Encourage Master Protocols; Outbreak Shows Need For Better Clinical Trial Infrastructure, CDER Director Woodcock Says

CBER Readies For A COVID-19 Vaccine: Seeking Manufacturing Capacity As It Helps Sponsors Plan Phase 2/3 Trials

Prevision Policy Clips | ICER Appoints SVP – Health Economics: Jonathan Campbell

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