Prevision Policy Clips | Oncology Cross Labeling FDA Draft Guidance

Oncologic Drug Dose Improvements Have Higher Profile At FDA During COVID; Review Teams Are Paying Attention To COVID Exposure Risk

Prevision Policy Clips | Trump “Most Favored Nation” Drug Pricing Threat Revived Again

Speaker’s Bureaus Under Scrutiny: IG Alert Offers Chance For Industry Re-Set Amid COIVD, Biden Transition

Prevision Policy Clips | COVID-19 Review Disruptions: Alkermes Antipsychotic Gets CRL, Bristol Liso-Cel Review Extended

Decentralized Oncology Trials: Early-Disease Treatments Could Boost Interest In Industry As COVID Changes Boost Experience At FDA

Time For Conditional Approval? Friends Of Cancer Research White Paper Points To Mandatory Annual Updates As Way To “Optimize” Accelerated Approval

Prevision Policy Clips | Moderna COVID-19 Vaccines: 94.5% Efficacy Gets NIH Co-announcement

“Beyond Breakthrough”: Streamlining “Redundant” Expedited Review Programs, Flexibility For Emerging Therapies Recommended By FOCR/FDA Group

Operation Warp Speed Involvement Has Driven Recognition of “Constant Pressure” On Industry, FDA’s Woodcock Says In NEJM Interview

FDA Under Biden: Back To The Future

Prevision Policy Clips | More Biosimilar FAQs Coming Soon: OMB Has Cleared FDA Guidance

FDA Should Push Back On State Plans To “Review” COVID Vaccines, Former Commissioner Gottlieb Says; Sees Parallel To Recent Fights With DoD, DoJ

Prevision Policy Clips | Biden White House Chief Of Staff Ron Klain Headed Ebola Response In 2014

HHS Transition Team: Long On Operational Experience – Not Drug Pricing Hawks

Prevision Policy Clips | Biden Agency Review Transition Team For HHS

“They Are Ready:” FDA Preparing To Bring Pfizer/BioNTech’s COVID Vaccine To Advisory Committee; Initial Meeting “Sets The Table” For Candidate Review

Prevision Policy Clips | Lilly EUA For Bamlanivimab Anti-COVID Antibody Includes Manufacturing Oversight Conditions

Real-World Data May Increase Clinical Trial Population Diversity, FDA Suggests In Final Guidance

COVID Transition Team Offers First Look At Potential Key Health Staff In Biden Administration; Future Preparedness May End Up As Major Focus

Biden Agenda On Drug Policy: Senate Result Will Be Key, But HR 3 Is Off The Table; COVID Response, User Fees, ACA Ruling Will Set The Tone

Biogen’s Aducanumab: Another Trial Likely Before Approval After FDA Panel Revolt; Accelerated Approval Is Less Likely Option

Prevision Policy Clips | November Surprise: Pfizer COVID Vaccine Interim Efficacy Above 90%

Prevision Policy Clips | So What About The Senate? Presidential Race Likely To Be Called Soon

Do REMS Work? FDA Proposes Public Disclosure Of Assessments, Plans December Workshop For “Path Forward” On Opioid REMS