Prevision Policy Clips | House FDA Appropriations Includes Funds To Support “Unannounced, In-Person Inspections”

Prevision Policy Clips | House FDA Funding Bill Would Increase Baseline Appropriations By $269 Million

FDA “Reassessing” Single-Arm PD-1 Oncology Trials: “Pazdur Moments” Lead To Advisory Committee Vote Against Incyte’s Retifanlimab Pending More Data

Complex Generics: Oligonucleotides May Feature In GDUFA-Funded Research; FDA Highlights COVID Lessons In Adoption Of New Modeling For BE Studies

Prevision Policy Clips | The Aduhelm Precedent In Action: FDA Grants “Breakthrough” Status To Novel Beta Amyloid Treatments

Woodcock’s FDA: Confident Decisions With Welcome Dissent

The Aduhelm Precedent: Beta Amyloid Correlation To Cognitive Data Is Key For Other Alzheimer Sponsors

CURES 2.0 Prods FDA On Familiar Topics More Than Seeking Major New Initiatives: RWE And Gene Therapies Sections Demonstrate Reminder Approach

Prevision Policy Clips | Biogen/Eisai Suggest Aduhelm Target Population Is 1-2 Million

Senate Democratic Drug Pricing "Principles" Retreat To Abstraction In Effort To Restart Price Negotiation Push; One Specific Is Repeal Of Rebate Rule

CDER Sought Extensive In-House Advice On Aduhelm Accelerated Approval, Cavazzoni Says; FDA Is On “Very Solid Ground” In Applying Pathway

Incyte’s Retifanlimab Response Rate In SCAC Topic Of Discussion At Advisory Committee; “Dangling” PD-1 Accelerated Approvals Cast Long Shadow

Prevision Policy Clips | Acting Commissioner Woodcock Highlights Opioid-Related Proposals In FY2022 Budget Request

Prevision Policy Clips | HHS Seeks Input On Drug Price And Rebate Reporting Requirement

Prevision Policy Clips | FDA Commissioner Search: Sen. Manchin Steps Up Opposition To Acting Commissioner Woodcock

RMAT Outpaces Breakthrough Designations At CBER; “Steep” Growth Curve Reflects Industry Interest In Designation Established Under 21st Century Cures

CBER To Individually Assess Ongoing Cell And Gene Therapy Trials In Post-COVID “Salvage” Effort, Director Marks Says

Model-Informed Drug Development Has Growing Role For CAR-T, Gene Therapy/Gene-Edited Products In Predicting Immunogenicity

Oncology “Core PROs” Guidance Continues FDA Effort To Collect More Patient Perspective—But In Manageable Amounts And Useful Forms

Prevision Policy Clips | Drug Pricing Remains Secondary Theme In HHS Budget Hearings; Aduhelm Not An Issue

FDA Advisory Committees Getting Overhaul (Again): Open Public Hearing, Conflict Of Interest Restrictions Among Initial Targets

COVID Clinical Trial Flexibilities Reflect “Sea Change” In FDA Reviewer Approach To Innovative Practices, Office Of New Drug Policy’s Smith Tells BIO

Prevision Policy Clips | Cures 2.0 Discussion Draft Is Coming Out In “Next Few Days”

Prevision Policy Clips | FDA Advisory Committee Overhaul: CDER Seeks "Greater Consistency And Less Surprises"

Prevision Policy Clips | Gardasil, Shingrix Could Benefit From Legislative Interest In COVID Vaccine Response