Virtual Disaster, But Unanimous Approval Vote For GSK’s Belantamab Mafodotin; ODAC Works Through Technical Challenges

Senate Democrats Urge FDA Public Review Of COVID-19 Vaccines Before Authorization As Part Of Ambitious Agenda For Securing Supplies And Delivery

Value-Based Pricing Rule: Portability Is “Biggest Issue” For Congress, Senate Finance Committee Staffer Says

Prevision Policy Clips | House E&C To Mark Up Health Legislation July 15

Mallinckrodt Terlipressin Heads To Committee: Treatment For Rare, Serious Condition Met Primary Endpoint – But FDA Having Second Thoughts On Surrogate; Will SPA Hold?

FDA Finalizes Four Guidances Broadening Oncology Trial Eligibility; Criteria For Patients With Brain Metastases Re-Crafted In More General Terms

Prevision Policy Clips | FDA Brain Metastases Patient Inclusion Guidance

GSK’s Belantamab Mafodotin For Multiple Myeloma: FDA Concerned With “Major” Ocular Safety Risk; Response Rate Probably Enough For ODAC

FDA Resuming Domestic Inspections July 20: Pre-Announced Only, And Limited By COVID Prevalence

Biden-Sanders “Unity Platform”: Moderate On Health Reform, Extreme On Drug Pricing; Price Review Board Is Theme To Follow

Prevision Policy Clips | FDA Appropriations Bill Moves To Floor With Mandatory Recall Authority Included

Rx Vials And Drug Prices: Population-Based Payments, Binding Arbitration, And Amazon Drones Overtake Dose Wastage At NASEM Meeting

FDA’s COVID-19 Vaccine 50% Efficacy Threshold Is “Reasonable” Compromise, CBER’s Marks Says; Rate Was Benchmarked Against Flu Vaccine

Prevision Policy Clips | Two Oncology At-Home Drugs Get FDA Expedited Reviews

Critical Drug List Model Adopted By Biden Campaign As Part Of Supply Chain Plan; Compulsory Licensing Threat Includes Reassuring Limits

Prevision Policy Clips | Biden Backs Critical Drug List Model As Key To Supply Chain Security

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