Rx Supply Chain Security Review By NASEM Will Run Until Early 2022: Will Review Slow COVID-Fueled Political Pressure For On-Shoring?

Prevision Policy Clips | House Oversight Drug Pricing Hearing Features Six Industry CEOs

FDA “Intended Use” Proposed Rule: Knowledge Of Off-Label Use Is Not Proof Of Intent On Its Own – But Could Be Considered

IND Safety Reporting Under COVID: FDA Says By-The-Book Process Still Applies – Though Reporting Thresholds Remains An Unsettled Area

Prevision Policy Clips | FDA “Intended Use” Proposed Rule: Knowledge Of Off-Label Use

Democratic Think Tank Proposes “March-In” Plan To Address Drug Prices In A Biden Administration; Any Shift Away From HR3 May Be Better Battleground For Biopharma

Prevision Policy Clips | HHS “Power Grab” Headlines: Import Policy – Not COVID-19 Vaccines – May Be Key Factor

Pediatric Safety Reviews: Committee Applauds FDA For Orencia Angioedema Warning Triggered By Single Case, Reviews ADHD, IGIV Label Updates

Prevision Policy Clips | Convalescent Plasma For COVID-19: FDA Will Use "Enforcement Discretion" For Plasma Collected Prior To The EUA

Prevision Policy Clips | “The Time Is Now”: CDC Director Redfield Urges Emergency Appropriation For COVID-19 Vaccine Distribution

COVID-19 Vaccine Launch Plan Offers More Specifics On Ancillary Supplies Than IT Systems; Final Priority Recommendations Still Pending

Prevision Policy Clips | Operation Warp Speed Phase I Coronavirus Vaccine Plan Will Distribute Vaccine In "Focused Manner"

FDA Guidance On COVID-19 Outpatient Therapies Includes Sample Symptom Assessment Tool; Time To Recovery (Not “Scores”) Is Recommended Endpoint

FDA Return-To-Normal Manufacturing Guidance Poses Questions On Impact Of Missing Technicians To Trustworthiness Of Supplies In Heavy Demand

Prevision Policy Clips | FDA Guidance For COVID-19 Outpatient Therapies

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