Prevision Policy Clips | No Sign Of Approval Slowdown At FDA: Three More NMEs Before Memorial Day

Advisory Committee Tracker: Incyte’s Retifanlimab Will Set Ominous Precedent; First Novel PD-1 Taken To ODAC

Prevision Policy Clips | FDA Aducanumab Decision Is National News: June 7 Deadline Previewed On Washington Post Front Page

FDA Data Modernization Plan Would Get Sizeable Increase In White House Budget, Callout For Congress To Work On Drug Price Negotiation Similar To HR 3

Provention Bio Teplizumab Wins Narrow Vote For Narrow Indication To Delay Type 1 Diabetes; Approval Still Hinges On Manufacturing Issues

Prevision Policy Clips | President’s Budget Coming Today: Drug Pricing Measures Expected To Be Left Out, Eyes On FDA

Prevision Policy Clips | Medicaid “Best Price” Reporting Changes To Enable VBP Would Be Delayed Six Months

Prevision Policy Clips | COVID Vaccine EUA Window May Close Soon, FDA Indicates

CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Is Driving Numbers; 20% Of Center Workforce Now Hired Under “Cures” Authority

Provention Bio Teplizumab To Delay Type 1 Diabetes: Favorable Outcome Likely At FDA Committee; Manufacturing Remains Key Obstacle To Approval

Peptide Generics FDA Final Guidance Keeps Focus On Characterization Of Impurities; Reiterates Victoza, Gattex, Forteo Are Peptides, Not Proteins

FDA Bispecific Antibody Final Guidance Maintains Language That Comparative Trials May Be Required In Some Cases

Inside FDA Patient Engagement: Agency Describes Rare Disease Listening Session Request; Insights Will Guide GSD1a Gene Therapy Trial Design

Prevision Policy Clips | CMS Administrator Nominee Brooks-LaSure Set For Confirmation Vote Today

“Project Optimus” Oncology Dose Finding Program Under Development At FDA; Effort To Move Away From “Maximum Tolerated Dose” In Cancer Trials

FDA Oncology “Beyond Breakthrough” Project Takes Shape: Review of Decade-Old Program To Result In “Menu” Of Benefits, Process For Rescinding Designation

FDA Digital Health Center Wants “Continuous Oversight” Rather Than “Episodic” Review For Software Products, Director Bakul Patel Tells FDLI Meeting

Prevision Policy Clips | FDA “Guidance Snapshot” Pilot

“Virtual” Inspections Can Take More Time Than Real Ones, FDA Finds; Sponsors Also Working Through Challenges With New Tools

The State Of CDER Under Cavazzoni: Shortage Surveillance Among COVID Tools To Be Retained; New Director’s Top Goal Is Winning “Hearts And Minds” Of Staff

Prevision Policy Clips | RMAT Designations: Biologics Center Continuing To Approve One-Third Of Submissions

Emergent/Janssen Awaiting FDA Response To Proposed Bayview Process Changes; Janssen Vaccine Production Could Start Within Days Of Acceptance

Ex-Commissioners See Mostly Positives In Public View Of FDA After COVID; Focus Should Be On Quality Of Guidance, Not Faster Reviews, McClellan Suggests

Prevision Policy Clips | FDA Confirms FibroGen/AstraZeneca Roxadustat Advisory Committee Meeting For July 15

Which CEO Is Next? House Drug Pricing Hearing Features Bipartisan Attacks On Industry Business Practices With AbbVie As The Target