Generic Drug Group Pushing For “American Allies” Supply Chain; Blueprint Calls For FDA Role To Relocate, Refurbish Plants

Remdesivir Emergency Use Authorization: Two Ways To Think About Government Drug Distribution

Prevision Policy Clips | FDA Commissioner Hahn, NIAID Director Fauci To Testify At Senate HELP Hearing May 12

Oncology FDA Approvals Ahead Of Schedule, Launched Into Challenging Environment; Oral Drugs Fare Better In A Disruptive Climate

Re-Opening FDA: Early Thoughts On The “New Normal”

Prevision Policy Clips | Regeneron's Coronavirus Antibody Treatment On Track For June Trials

Rx Vial Size: FDA Defends Safety First Approach As NASEM Starts Work On Proposals To Reduce “Wastage” Of High Cost Drugs

CMS COVID-19 Interim Rule Expands Coverage Of Drug Administration To Temporary Outpatient Hospital Locations – Including Patient Homes

Prevision Policy Clips | Gilead Remdesivir Emergency Use Authorization Uses Federally-Managed Restricted Distribution Plan

Tracing And Wholesale Distribution Requirements Lifted For COVID-19 Products Under Temporary FDA Policy; Remdesivir Would Be Covered

CDER Details Three-Step Safety Signal Evaluation Process, Sets Rules For How FDA Will Handle Signals; Transition To New System Comes Amid Workplace Disruption

Prevision Policy Clips | Gilead Remdesivir At FDA: Company Expects “Two Step” Approval Process

Prevision Policy Clips | White House Advisor Grogan To Leave Administration In May

Cures II “Concept Paper” Proposes Formal Role For Real-World Evidence In Breakthrough Therapy, Accelerated Approval Decisions

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

Loading More