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Informed Consent Flexibility Is Focus Of Latest Revisions To FDA Guidance On COVID-Affected Trials
July 6, 2020
HHS May Turn To National Academy Of Medicine For Help On First Populations For COVID Vaccines; NIH Remains Opposed To “March In”
July 6, 2020
Prevision Policy Clips | PDUFA Stakeholder Meetings: FDA Sets Initial August 17, 2020 Notification Deadline
July 6, 2020
Prevision Policy Clips | ICER Cancels NASH Public Meeting Reviewing Obeticholic Acid
July 2, 2020
Prevision Policy Clips | Where Is The EUA? Dexamethasone Largely Unmentioned During Senate Hearing
July 1, 2020
HHS Regulatory Agenda Includes IPI And Import Rules, But Election Will Dictate Impact; FDA “Intended Use” Definition Under Development
June 30, 2020
FDA Vaccine Development Guidance: Narrow Window For Emergency Use Authorization At Year End; Safety Focus Is On Respiratory Exacerbation
June 30, 2020
Operation Warp Speed At ACIP: Vaccines Lead Hepburn Welcomes “Advice” – But Not Typical Channels Of HHS Control
June 30, 2020
Prevision Policy Clips | Drug Pricing Bill Fades As Wyden Walks, Chairman Grassley To Make Last Ditch Effort
June 30, 2020
FDA Anti-Infective Product Development Guidance For Pediatric Populations Recommends Efficacy Extrapolation Where Appropriate
June 29, 2020
Advisory Committee Tracker: First “Virtual” Meeting Set For July, With Review Of GSK Myeloma Therapy; NASH Review No Longer Pending After FDA Rejects OCA
June 29, 2020
Prevision Policy Clips | Gilead Beats ICER Price On Remdesivir: HHS Will Pay $2,300 Per Course Of Treatment
June 29, 2020
ICER Updates Cost Effectiveness Analysis For Remdesivir To Take Into Account Dexamethasone Trial; Pandemic Assessments May Increase Attention To ICER
June 26, 2020
Prevision Policy Clips | Senate Appropriations To Hold Operation Warp Speed Hearing July 2
June 26, 2020
Pandemic Lessons In Continuous Funding: Senate HELP Hearing Features Unity Behind Health Defense Budget, Domestic Manufacturing Investments
June 25, 2020
FDA Finalizes Community-Acquired Bacterial Pneumonia Guidance; Efficacy Endpoint, Trial Population Updates Among Major Changes
June 25, 2020
Prevision Policy Clips | HR3 Drug Pricing Provisions Part Of Democratic Election Strategy Bill
June 25, 2020
COVID-19 Biologics Face Manufacturing Capacity Issues; 60% Of Current Bioreactor Capacity Controlled By Companies With Their Own Biologic Products
June 24, 2020
Virtual Inspections To Address Pandemic Travel Difficulties May Be Considered By FDA; Video Accompaniment With European Inspectors Is One Option
June 24, 2020
Prevision Policy Clips | Oncology Center Of Excellence Unveils “Project Patient Voice” With Treatment Symptom Frequency Chart
June 24, 2020
FDA Amid COVID: Agency Plans To Prioritize Inspections Based On “Expected Health Benefit” – While Still Meeting User Fee Goals; House Hearing Gentle On FDA
June 23, 2020
FDA May Assess NDA Complexity To Estimate Future User Fee Needs; PDUFA Consultant Suggests Factoring In Post-Market Safety, Guidances
June 23, 2020
Prevision Policy Clips | FDA Bioavailability/Bioequivalence Sample Compliance Guidance Forwarded To OMB
June 23, 2020
NCI Seeks To Restart Oncology Trials Engine After Low Accruals During Pandemic; Paying Grantees While Trials Are Stalled Is Spending Down NCI Effort
June 22, 2020
Prevision Policy Clips | Remdesivir Inhaled Version To Enter Phase I Trials This Week
June 22, 2020
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