Prevision Policy Clips | Biogen Aducanumab Alzheimer’s Treatment Advisory Committee Set For Nov. 6

FDA’s Digital Health Center of Excellence Will Not Accept Or Approve Applications; “Single Hub” For Health Tech Gets No New Funding

DoD “Operation Warp Speed” Team Developing Computer Platform “Tiberius” To Help Local Entities On Planning, Administration Of COVID-19 Vaccines

Rx Importation Final Rule: Will The Precedent Survive The Politics?

Prevision Policy Clips | Rx Import Final Rule Released: Takes Effect After November Election, With Additional Lag Time For FDA Review

Operation Warp Speed’s Slaoui Says Coronavirus Vaccine Ahead Of Schedule: Predicts 2020 Rollout To “Part Of The Population” At NVAC

CDC Advisory Committee May Double-Check FDA COVID Vaccine Authorization By Asking For Clinical Trial Data To Conduct Independent Review

Prevision Policy Clips | FDA Import Rule Clears OMB, Publication Likely Imminent

Real-World Evidence Uptake Is “Silver Lining” Of COVID-19: Pandemic Is Forcing Stakeholders To “Get Comfortable” With RWD Ahead Of PDUFA VII

FDA Credibility Still Intact: Senate Hearing Treats Commissioner Hahn As Trustworthy Voice – While Dems Extract Clear Commitments For Vaccine Transparency

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