FDA Benefit-Risk Assessment Is Based On Overall Population – Not Tolerance Of Individual Patients, Agency Says In New Guidance On Core Regulatory Actions

Pulmonary NTM Drug Developers Should Not Depend On “Microbiological Endpoints” For Primary Efficacy Claim, FDA Says In Draft Guidance

Prevision Policy Clips | Gene/Cell Therapy Guidance Describes Regulatory Framework For Early Studies

FDA’s Starting Point For Real-World Data: “Reliability And Relevance” In EHR/Claims Data; First Of Several 2021 RWE Guidances Released By Agency

PDUFA VII Public Meeting: Gene Therapy Support Is Powerful Theme; Consumer Groups Push Back On Remote Inspections

Prevision Policy Clips | Biogen/Eisai Seek Accelerated Approval Of Lecanemab For Alzheimer’s Disease With Initiation Of Rolling BLA

BsUFA III Agenda On Interchangeable Biologics Includes Four New FDA Guidances, Regulatory Science Pilot Program

Prevision Policy Clips | HR3, Repeal Of “Rebate Rule” Are In Reconciliation Package

Biosimilar Development: Biological Complexity, Regulatory Uncertainty Are Key Barriers To Adoption Of Pharmacodynamic Biomarkers, Sponsors Tell FDA/Duke Workshop

Prevision Policy Clips | OMB Receives HHS Proposed Rule On “Top 50” Drug Reports

FDA, CDC Meet Biden Booster Deadline, Barely: Pfizer/BioNTech COVID Vaccine Third Dose Recommended For “Limited” – But Still Large – Population

Value-Based Purchasing Interest Gaining Momentum In Medicaid; Will States View Tracking Effort Worth The Potential For Additional Rebates?

Prevision Policy Clips | ODAC Review Of Farydak, Marqibo Set For Dec. 2; Two Additional “Dangling” Accelerated Approvals

Teva’s Paliperidone One-Month Injectable, Cipla’s Difluprednate Ophthalmic Emulsion Cited By FDA’s Woodcock As Evidence Of Progress On Complex Generic Approvals

Medicaid Programs Must Cover Aduhelm, CMS Says; Accelerated Approval Criticisms Sticking Broadly For All Drugs When It Comes To Reimbursement

Prevision Policy Clips | JAK Inhibitor Reviews Resume: Incyte Opzelura (Topical Ruxolitinib) Approved By FDA With Boxed Warning

BsUFA III Agreement Revamps Biosimilar Supplement Review Timelines; FDA Gets 10% Raise To Support 15 New FTEs

Prevision Policy Clips | BsUFA III Agreement Set For Public Review At Nov. 2 Meeting

Drug Development “Snapshots” To Expedite “Breakthrough” Communication Proposed By FOCR Working Group; Dosing Could Be Good Starting Point For Pilot Tests, FDA Suggests

Pfizer/BioNTech COVID-19 Boosters Nearly End In Complete Failure; CBER’s Marks Helps To Salvage Application With A Narrowed Indication – But At What Cost?

Prevision Policy Clips | Pfizer Announces Positive Data For COVID-19 Vaccine In 5-11 Year Olds; EUA Submission Planned “As Soon As Possible”

Prevision Policy Clips | Biosimilars Q&A Guidance Finalized: FDA Transfers Some Questions, Withdraws Others

Gene Therapy Sponsors Engage In FDA Safety Review: Pfizer Describes Enhanced Lab Monitoring For DMD Therapy To CBER Committee

Prevision Policy Clips | HR3 Fails In Committee; Now The Real Negotiations Begin?

Pfizer/BioNTech COVID-19 Booster Advisory Committee Will Air FDA Internal Disputes: Briefing Documents Advise Caution, While Leadership Favors Approval