FDA Related News

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Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...

Medical Devices

DeepWell Digital Software Cleared for Stress Relief

FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...

Federal Register

Whole Exome Sequencing Devices are Class 2

Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).

Federal Register

Aisa Pharma Orphan Status for Cilnidipine

Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis.

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Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...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