FDA Related News

Human Drugs

CGMP Violations at Zydus Lifesciences Facility

FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Medical Devices

Multiple Optikem International Violations Cited

FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthalmic solutions.

Changes Sought in FDA Misinformation Guidance

Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...

Medical Devices

FDA Clears Sonic Incytes Velacur Device

FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Federal Register

Priority Voucher Used on Incytes Opzelura

Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority review voucher.

Human Drugs

FDA Mulls More Post-Inspection Feedback: Cavazzoni

CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...

Federal Register

Class 2 for Endoscopic Pancreatic Debridement Devices

Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).

Biologics

CBER Updates Refusal-to-File Procedure

CBER posts an updated standard operating policy and procedure (SOPP) manual entitled SOPP 8404: Refusal to File (RTF) Procedures.

Federal Register

Cell-Free Nucleic Acid Collector is Class 2

Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.

Human Drugs

GSK Highlights Depemokimab Asthma Data

GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation.