LPAD Final Guidance Makes Clear That FDA Can Choose Traditional Approval Route If Agency Sees Fit; Flexibility In Review Is More Important Than LPAD Tag

Insurers To Be “Price Acceptors” For COVID Treatments, Cigna’s Miller Says During ICER Session; Where Is US Version Of RECOVERY Trial?

Prevision Policy Clips | Limited Population Antibiotics Final Guidance

340B Payment Cuts Would Deepen Under Medicare Hospital Outpatient Proposed Rule; 505(b)(2) Part B Coverage Policy Would Be Codified In Physician Rule

Prevision Policy Clips | CMS Proposes Bigger 340B Payment Cut After Appeals Court Victory: ASP-28.7%

COVID-19 Vaccine Reviews: FDA May Skip Advisory Committee In Interest Of Timeliness Of Decisions

Prevision Policy Clips | Lilly, NIH/NIAID Partner On Coronavirus Antibody Trial In Long-Term Care Facilities, Will Use RVs

Cost-Recovery Pricing For COVID Products Draws Mixed Reactions At ICER; Favors Big Companies, Raises Issue On Relevance Of Acquisition Spending

FDA Oncology Center Studying Variability Of Results From Remote Trials During COVID-19; Pandemic “Natural Experiment” For Community-Based Cancer Trials

Prevision Policy Clips | CDER/CBER Hiring Pilot Shortened Time To Hire New Staff By 60%

Advisory Committee Tracker: ODAC Tries Virtual Again In August; Several Sponsors Await Fall Meeting Dates

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