FDA Related News

Human Drugs

Ocaliva Confirmatory Trial Fails: FDA

FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocaliva to treat some cas...

Biologics

GSK Nixes Herpes Simplex Virus Vaccine

GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recent Phase 1-2 study.

Medical Devices

Hinge Health Wireless Pain Device Cleared

FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

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Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...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

Follow FDA Online Misinformation Guidance: Attorneys

Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...