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Accelerating COVID-19 Vaccines: Pre-BLA “White Space” Could Be Good Time For EUA, CBER Director Says; Too Many Chefs Overseeing Federal Effort?
May 14, 2020
Prevision Policy Clips | Ex-GSK Vaccine Head Slaoui Floated As Lead For “Operation Warp Speed”
May 14, 2020
Prevision Policy Clips | Intercept May Be First “Virtual” Advisory Committee: NASH Indication Review June 9
May 13, 2020
Senate HELP Hearing On COVID-19: FDA Commissioner Hahn Avoids Hot Seat As Focus Turns To States’ Ability To Safely Reopen
May 12, 2020
Antibiotic Pass-Through Payment Would Be Faster Under CMS Proposal; CAR-Ts Headed For Separate Payment In Medicare Inpatient Setting
May 12, 2020
Infected Trials III: FDA Wants Updated Timelines For Post-Marketing Requirements ASAP; Compliance Implications May Not Be Clear Until Original Deadline Arrives
May 12, 2020
FDA COVID-19 Treatment Guidance: Pre-IND Is Starting Point, Placebo-Controlled Studies With Clinical Outcomes Is End; Platform Trials “May Be Appropriate,” But No Specific Advice
May 12, 2020
FDA Manufacturing Inspections Update: “Case-By-Case” Approach Continues Until On-Site Visits Can Resume Under “Phased Approach”
May 12, 2020
Prevision Policy Clips | FDA COVID-19 Updates Ahead Of Senate Hearing
May 12, 2020
Generic Drug Studies For ANDA Registration Facing COVID-19 Concerns: Generic Industry Hopes FDA Will Adopt More Flexibility In Response – And Perhaps Maintain That Approach Post-COVID
May 11, 2020
Prevision Policy Clips | FDA Commissioner Hahn In Self-Isolation After Possible COVID-19 Exposure
May 11, 2020
Exit Interview With Joe Grogan: “Deal To Be Had” On Part D Redesign Before The Election; White House DPC Will Shift To Campaign Mode
May 9, 2020
Prevision Policy Clips | ACTIV Update: COVID-19 Partnership Has 170 Therapeutic Candidates Under Review
May 8, 2020
Prevision Policy Clips | Trump Administration Health Policy Leadership Shifts Back To HHS
May 7, 2020
Generic Drug Group Pushing For “American Allies” Supply Chain; Blueprint Calls For FDA Role To Relocate, Refurbish Plants
May 6, 2020
Remdesivir Emergency Use Authorization: Two Ways To Think About Government Drug Distribution
May 6, 2020
Prevision Policy Clips | FDA Commissioner Hahn, NIAID Director Fauci To Testify At Senate HELP Hearing May 12
May 6, 2020
Oncology FDA Approvals Ahead Of Schedule, Launched Into Challenging Environment; Oral Drugs Fare Better In A Disruptive Climate
May 5, 2020
Re-Opening FDA: Early Thoughts On The “New Normal”
May 5, 2020
Prevision Policy Clips | Regeneron's Coronavirus Antibody Treatment On Track For June Trials
May 5, 2020
Rx Vial Size: FDA Defends Safety First Approach As NASEM Starts Work On Proposals To Reduce “Wastage” Of High Cost Drugs
May 4, 2020
CMS COVID-19 Interim Rule Expands Coverage Of Drug Administration To Temporary Outpatient Hospital Locations – Including Patient Homes
May 4, 2020
Prevision Policy Clips | Gilead Remdesivir Emergency Use Authorization Uses Federally-Managed Restricted Distribution Plan
May 4, 2020
Tracing And Wholesale Distribution Requirements Lifted For COVID-19 Products Under Temporary FDA Policy; Remdesivir Would Be Covered
May 1, 2020
CDER Details Three-Step Safety Signal Evaluation Process, Sets Rules For How FDA Will Handle Signals; Transition To New System Comes Amid Workplace Disruption
May 1, 2020
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