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Prevision Policy Clips | White House Advisor Grogan To Leave Administration In May
April 30, 2020
Cures II “Concept Paper” Proposes Formal Role For Real-World Evidence In Breakthrough Therapy, Accelerated Approval Decisions
April 29, 2020
COVID-19 Vaccines: Experience From Ebola, Previous Production Expansions Suggest Tough Challenges Ahead; Danger Of “Over-Promising”?
April 29, 2020
Prevision Policy Clips | FDA Approves Less-Frequent Dosing For Merck’s Keytruda Amid COVID-19 Disruptions
April 29, 2020
Advisory Committee Tracker: Preparing For Virtual Reality – Which Sponsor Will Go First?
April 28, 2020
Prevision Policy Clips | FDA Data Strategy Public Meeting Rescheduled For June 30
April 28, 2020
Prevision Policy Clips | HHS Secretary Azar Not Being Fired, President Trump Tweets
April 27, 2020
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
April 24, 2020
Prevision Policy Clips | HHS Infighting Casts Large Shadow Over COVID-19 Response
April 24, 2020
FDA Guidance On COVID-19 Trials Likely To Encourage Master Protocols; Outbreak Shows Need For Better Clinical Trial Infrastructure, CDER Director Woodcock Says
April 23, 2020
CBER Readies For A COVID-19 Vaccine: Seeking Manufacturing Capacity As It Helps Sponsors Plan Phase 2/3 Trials
April 23, 2020
Prevision Policy Clips | ICER Appoints SVP – Health Economics: Jonathan Campbell
April 23, 2020
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
April 22, 2020
Prevision Policy Clips | BARDA Leadership Shuffle Adds To Challenges Of Crisis Collaboration
April 22, 2020
Real-World Evidence Effort At FDA Ramps Up Amid COVID Response; Plaquenil Plays Pivotal Role
April 21, 2020
COVID Collaborations: “ACTIV” Aims For Near-Term Therapies, But Long-Term Implications Could Shape Future Of Public-Private Models
April 21, 2020
Prevision Policy Clips | FDA Planning Guidance On COVID-19 Product Development
April 21, 2020
Prevision Policy Clips | Seattle Genetics’ Tukysa Is First NME Approved Under OCE “Project Orbis”
April 20, 2020
ICER Patient Engagement Seeks More PRO/RWE Data; Looking To Turn Patient Advocates From Critics Of Cost Effectiveness Reviews Into Allies
April 17, 2020
FDA Advice On Remote Data Collection During COVID: Consistency Is Key, And May Not Always Be Possible; Bottleneck Likely In Seeking Input From Divisions
April 17, 2020
Prevision Policy Clips | FDA Updates Clinical Trials Guidance Again; Clinician-Reported And Performance Outcome Assessments May Not All Be Feasible Remotely
April 17, 2020
NDAs At Risk Of Delay? Oncology, Neurology Have Most Near-Term Deadlines At FDA, But Lower-Priority Applications At Higher Risk Amid COVID Disruptions
April 16, 2020
Prevision Policy Clips | NIH Trial Balloon For COVID Trials
April 16, 2020
Global Regulatory Convergence Urged For Regenerative Medicine; BioMarin Policy Head Proposes Topics For FDA Attention
April 15, 2020
NCI Accelerating Access To Genentech’s Actemra For Cancer Patients With COVID-19 Through “Treatment Referral” Program
April 15, 2020
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