Trump Drug Pricing Strategy: Teeing Up Headlines As Voting Gets Under Way

OxyContin Reformulation: FDA Gets What It Wants In Public Airing Of “Real World” Data; Committee Backs FDA View Of Modest Impact From “ADF” Version

Oncology Care Model Disappointing So Far As Medicare Is Not Saving Money; CMMI’s Strawbridge Says CMS Is Discussing Drug Utilization Changes

CBER “Wear And Tear” From COVID; Fast Turnaround For Pandemic Projects Is Changing Level Of Communication In Other Areas Like Gene Therapy

Prevision Policy Clips | President Trump Tees Up Drug Pricing Headlines For Campaign Crunch Time

Prevision Policy Clips | Resuming “Normal” Drug/Biologic Manufacturing Guidance Highlights Resumption Plan Elements

COVID-19 Vaccines Likely Available Through “EUA-Plus” Pathway, FDA’s Marks Says; More Guidance Coming On Emergency Use Standards

Prevision Policy Clips | FDA’s Woodcock, Marks, Cavazzoni Reaffirm FDA Scientific Independence Despite Trump Pressure

WHO Will Ask Vaccine Sponsors Going EUA Route To Share All Data On Decision: International Impact Of FDA Politicization Publicity

COAs For Rare Diseases: FDA Reviewers Look For More External Help In Developing New Outcome Assessment Tools In Four Areas

Prevision Policy Clips | FDA Alert On Tecentriq And Paclitaxel Combo

Where Are The Pre-Approval Inspections? Recent FDA Reviews Show “Normal” Is Still A Long Way Off

Medicare Coverage For Vaccines: MedPAC Likely To Reiterate Call For Part B Coverage For All Vaccines, But With New Pricing Approaches

OxyContin ADF Impact: FDA Concludes Re-Formulation Shifted Abuse Patterns, But No Clear Effect On Overall Abuse, Overdose Or Public Health

Prevision Policy Clips | The Vaccine Pledge

FDA Office Of Neuroscience Leadership Commitment To Data Sharing Is Strong; NORD/CPath Platform Project Looks For Similarities Between Rare Diseases

Prevision Policy Clips | Biotech CEOs Call For FDA Independence In Vaccine Authorization Decision

CMS Grants Add-On Status To Nine New Rx Products But Sage Zulresso Falls Short: Antibiotics Dominate NTAP Class Of ‘21; Two PD1 Cancer Drugs Treated As One

COVID-19 Vaccine Allocation Would Start With Health Care Workers Under NAM Draft Framework; Other Stakeholders Jockey For Preferred Positions

Prevision Policy Clips | FDA Commissioner Hahn To Testify In Senate Hearing Sept. 23

Payers Preparing For Biogen’s Alzheimer’s Candidate Aducanumab – Or A Future Disease-Modifying Therapy: New Payment Models Wanted

Nitrosamine Assessments Expected For All NDA/ANDA Submissions Effective Immediately, FDA Says In New Guidance; All Marketed Products Should Be Assessed For Risk In Six Months

Prevision Policy Clips | FDA Gives Drug Manufacturers Six Months To Complete Nitrosamine Risk Assessment For Marketed Products

Prevision Policy Clips | House E&C Committee Plans Hearing On FDA COVID Response

GSK Trelegy Survival Claim Shot Down By FDA Committee; Discussion May Have Implications for COPD Safety Labeling On Inhaled Steroid Withdrawal