Drug Development In Older Patients: “Over-65” Subgroup “No Longer Good Enough,” FDA’s Temple Says; Opening For Geriatric Study Incentives?

Prevision Policy Clips | Biogen Alzheimer’s BLA Accepted By FDA: Advisory Committee Likely Ahead Of March 7, 2021 User Fee

FDA Directed To Create "Essential Medicines" List Under Trump “Buy American” Executive Order

Prevision Policy Clips | FDA Commissioner Hahn Pens Editorial In Washington Post: COVID-19 Vaccine Review Will Be Science-Based

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