Prevision Policy Clips | Krystal Biotech’s HSV-1 Viral Vector Receives FDA Platform Designation

“Hybrid” Inspections Final Guidance: Sponsors That Decline To Accept Remote FDA Participation In Pre-Approval Inspections May “Prolong” Process

Prevision Policy Clips | AstraZeneca Pricing Deal Follows Pfizer Template

Prasad’s CBER Takes Shape: Promotions Include Two Deputies To Share Number-Two Spot; Goldberg Is Now CMO, Steele To Oversee Pandemic Preparedness

Federal Procurement Policy May Be Tool To Increase Domestic Manufacturing of Generic Drugs, Senate Aging Committee Leadership Suggests; Country-of-Origin Labeling Also Has Bipartisan Support

Prevision Policy Clips | FDA Posts Five More CRLs, With Another Coming Soon

Oncology PROs Should Capture Specific Measurements Of Toxicity; Use Of Global Quality-Of-Life Assessments To Claim Tolerability Is “Not Acceptable,” FDA Says

Prevision Policy Clips | CMMI “Exploring” GLP-1s For Weight Loss Model

Malaria Trials May Use Non-FDA Approved Comparators, Draft Guidance Says, But FDA Approved Controls Preferred; Fourth Anti-Infectives Guidance Of Trump Era

FDA GERD/Erosive Esophagitis Draft Guidances Come Amid Revival Of Drug Development In Class Long Dominated By PPIs

Prevision Policy Clips | Former CBER Director Peter Marks Joins Lilly As SVP

FDA Quantitative Medicine Center of Excellence Details Long-Term Plans To Drive QM Adoption And Optimization; “Innovation Network” Is One Objective

Prevision Policy Clips | Medicare Coverage For GLP-1s For Obesity: CMS’ Oz Suggests Action Coming “Very Soon”

Prevision Policy Clips | FDA Postpones Select Panel Discussion On Food Allergies

FDA Deadline Tracker: Agency Tops 30 NMEs In 2025, But No More Talk Of “Record Year”; Shutdown Uncertainty Adds New Risk To Review Performance

Prevision Policy Clips | FDA Launches ANDA Priority Review Pilot

FDA PreCheck Domestic Manufacturing Initiative Gets Positive Feedback From Industry With Focus On Pre-Approval Inspections

FDA Reiterates Cautious, Iterative Approach To Novel Cancer Endpoints; Added Development Time Helps Build Buy-In From Clinical Community

Prevision Policy Clips | FDA To Consider Narrowed Indication Under “Expedited Re-Review” Of Vanda's Hetlioz For Jet Lag

FDA Rx User Fee Carryovers Are About $450 Million At Start Of Shutdown, Financial Report Indicates

Price Negotiation Year Three: CMS Final Guidance Drops Threat To SubQ Biologic Formulations For Now; Keytruda, Opdivo Exempt Under New Orphan Drug Language

Insmed Brinsupri Pricing “Overreach” Criticized By ICER Panel; First Non-CF Bronchiectasis Treatment Hailed As “Game Changer,” But $60,000 Annual Price Draws Rebukes

Prevision Policy Clips | Shutdown Begins: FDA Publicly Affirms All Critical Safety Activities Will Continue

Pfizer/Trump Drug Pricing Deal Suggests Template For Industry: MFN Price For Medicaid, Promise US Gets Lowest Launch Prices Going Forward; Details Remain Vague

Advisory Committee Tracker: VRBPAC Comes Back, But Product-Focused Advisory Committees Have Vanished