Right-To-Try Proposed Rule Details Process, Timelines For Annual Sponsor Summaries To Agency On Drugs Made Available To Patients

Pfizer $1.95 Billion COVID-19 Vaccine Contract Sustains Warp Speed Narrative On October Delivery; Domestic Production Efforts Have Bipartisan Appeal

Prevision Policy Clips | Right To Try Proposed Rule Would Create Separate Submission Process, Set Deadlines And Details For Annual Summaries

Virtual Advisory Committees Need Live Video Feeds, FDA Official Acknowledges, But Considers Regulatory Discussions A “Success”

GDUFA III Initial Lines Drawn As FDA Touts Success And Notes Growing Meeting Requests; Industry Wants Better First-Cycle Approval Rate; Teva Gets Bold

Prevision Policy Clips | Mesoblast Stem Cell Therapy Treatment Is Subject Of ODAC Review August 13

OCE Unveils “Project Patient Voice” With Tagrisso Symptom Frequency Analysis; AstraZeneca Pilot Is “Version 1.0;” More Work Needed

Prevision Policy Clips | FDA Extends Regenerative Medicine Enforcement Discretion Period To May 2021

Prevision Policy Clips | RWE For Vaccine Efficacy: FDA Virtual Workshop September 17-18

Real World Data Could Complement Survival Findings For Dexamethasone In COVID-19, FDA Deputy Abernethy Suggests; RECOVERY Trial Is “Blunt Instrument”

Prevision Policy Clips | FDA Digital Health Center Of Excellence Still Planned To Start In 2020

Mallinckrodt Terlipressin Approval Hinges On Risk Management Dialogue With FDA After Split Committee Vote; Second “Virtual” Review Goes More Smoothly Than First

Stockpile Bill With Manufacturing Pilot Program Added To Energy & Commerce Package Of Health Bills For Full House Following July 15 Markup

Prevision Policy Clips | Closing The Books On Lartruvo: FDA Formally Withdraws Lilly BLA

Prevision Policy Clips | ODAC Votes Unanimously In Favor Of GSK Multiple Myeloma Drug After Technical Nightmare

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