FDA Tech Modernization Program Being Driven By New IT/Data Team At Agency and HHS: Big Plans To Change Speed Of Operations Meet Reality

Prevision Policy Clips | Drug Pricing Executive Order Coming, White House Chief of Staff Says In “Sneak Preview”

Informed Consent Flexibility Is Focus Of Latest Revisions To FDA Guidance On COVID-Affected Trials

HHS May Turn To National Academy Of Medicine For Help On First Populations For COVID Vaccines; NIH Remains Opposed To “March In”

Prevision Policy Clips | PDUFA Stakeholder Meetings: FDA Sets Initial August 17, 2020 Notification Deadline

Prevision Policy Clips | ICER Cancels NASH Public Meeting Reviewing Obeticholic Acid

Prevision Policy Clips | Where Is The EUA? Dexamethasone Largely Unmentioned During Senate Hearing

HHS Regulatory Agenda Includes IPI And Import Rules, But Election Will Dictate Impact; FDA “Intended Use” Definition Under Development

FDA Vaccine Development Guidance: Narrow Window For Emergency Use Authorization At Year End; Safety Focus Is On Respiratory Exacerbation

Operation Warp Speed At ACIP: Vaccines Lead Hepburn Welcomes “Advice” – But Not Typical Channels Of HHS Control

Prevision Policy Clips | Drug Pricing Bill Fades As Wyden Walks, Chairman Grassley To Make Last Ditch Effort

FDA Anti-Infective Product Development Guidance For Pediatric Populations Recommends Efficacy Extrapolation Where Appropriate

Advisory Committee Tracker: First “Virtual” Meeting Set For July, With Review Of GSK Myeloma Therapy; NASH Review No Longer Pending After FDA Rejects OCA

Prevision Policy Clips | Gilead Beats ICER Price On Remdesivir: HHS Will Pay $2,300 Per Course Of Treatment

ICER Updates Cost Effectiveness Analysis For Remdesivir To Take Into Account Dexamethasone Trial; Pandemic Assessments May Increase Attention To ICER

Prevision Policy Clips | Senate Appropriations To Hold Operation Warp Speed Hearing July 2

Pandemic Lessons In Continuous Funding: Senate HELP Hearing Features Unity Behind Health Defense Budget, Domestic Manufacturing Investments

FDA Finalizes Community-Acquired Bacterial Pneumonia Guidance; Efficacy Endpoint, Trial Population Updates Among Major Changes

Prevision Policy Clips | HR3 Drug Pricing Provisions Part Of Democratic Election Strategy Bill

COVID-19 Biologics Face Manufacturing Capacity Issues; 60% Of Current Bioreactor Capacity Controlled By Companies With Their Own Biologic Products

Virtual Inspections To Address Pandemic Travel Difficulties May Be Considered By FDA; Video Accompaniment With European Inspectors Is One Option

Prevision Policy Clips | Oncology Center Of Excellence Unveils “Project Patient Voice” With Treatment Symptom Frequency Chart

FDA Amid COVID: Agency Plans To Prioritize Inspections Based On “Expected Health Benefit” – While Still Meeting User Fee Goals; House Hearing Gentle On FDA

FDA May Assess NDA Complexity To Estimate Future User Fee Needs; PDUFA Consultant Suggests Factoring In Post-Market Safety, Guidances

Prevision Policy Clips | FDA Bioavailability/Bioequivalence Sample Compliance Guidance Forwarded To OMB