Senate HEALS Act Draft Includes $6 Billion For COVID Vaccine Distribution; CDC Would Be Responsible For Budget And Strategic Planning

Prevision Policy Clips | FDA Revises Guidance On pCR As Endpoint In Neoadjuvant Breast Cancer Treatment

Prevision Policy Clips | FDA Forwards “Intended Use” Amendments Proposed Rule To OMB

FDA Refuse-To-File Letters For NDAs Tick Up To Record Levels; Increase Comes Amid Record Filing Levels—But Also "Program" Changes

Prevision Policy Clips | COVID Vaccine Distribution Would Be Led By CDC With $6 Billion Allocation Under Senate Bill

Prevision Policy Clips | Pharma Leaders To Respond To Trump On IPI Threat At July 28 White House Meeting

Trump Signs Three Orders And A Threat: Rebate Rule, Importation Will Move; Biopharma Has IPI Deadline With Shifting Political Climate On The Horizon

Prevision Policy Clips | Drug Pricing Executive Orders On White House Schedule

PDUFA VII Reauthorization Season Opens: Stakeholders Call For User Fees To Support FDA Activities In Cell/Gene Therapy, Digital Health

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