ODAC Delivers Favorable Efficacy Vote In Milestone Event For First-In-Class Cell Therapy In Spite Of Many Unknowns; Will FDA Be Moved To Approve?

Drug-Drug Interaction Draft Guidance For Therapeutic Proteins Stretches Into Other CBER Categories: Gene And Cellular Therapies

Prevision Policy Clips | NS Pharma’s Viltepso Is Third Exon-Skipping DMD Therapy Approved By FDA, And Second Targeting Exon-53

FDA Interest In “Stable” Disease During Antifungal Treatment Suggests Willingness To Change: Workshop During COVID Shows Engagement

Prevision Policy Clips | CBER Director Peter Marks Is Front-Page News

FDA Communication Get Strong Marks From Outside Report; Industry Still Sees Room For Improvement In Consistency Of Best Practices

COVID Vaccine Process – First Lessons: US Lost Time Signaling Interest To Sponsors; Continued Interest In Second, Third Generation Vaccines Critical

ODAC Will Tackle Quality And New Tech In Complex Virtual Review Of Mesoblast Novel Cell Therapy; Another Trial Appears Very Likely

Prevision Policy Clips | Male Breast Cancer Drug Development Guidance Finalized

Prevision Policy Clips | GSK Trelegy COPD Mortality Benefit Will Be Discussed By FDA Advisory Committee on August 31

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