FDA Related News

Federal Register

FDA Backs Bioinformatics Computations/Analyses Standard

Federal Register notice: FDA announces its support for use in regulatory submissions of the current version of an international standard for bioinform...

Human Drugs

Congresspeople Question Drug Dog Tests

Some 18 members of Congress ask FDA to report on its regulatory requirements and recommendations for testing drugs on dogs.

Human Drugs

Cancer Patients Have Greater Covid Risk: OCE Analysis

The FDA Oncology Center of Excellence says its analysis of real-world data shows that cancer patients with Covid-19 are at greater risk of hospitaliza...

Medical Devices

Integra LifeSciences Ultrasonic Surgical Device Cleared

FDA clears an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for resection of tumors.

Medical Devices

BD Expanded HPV Assay Approved

FDA approves a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay.

Human Drugs

FDA Preparing for Combined Flu/Covid-19 Tests This Fall

FDA commissioner Stephen Hahn says the agency is evaluating several different tests that can simultaneously test for both the flu and Covid-19 as part...

Federal Register

More Class 2 Devices Exempt from 510(k)

Federal Register notice: FDA publishes an order to exempt a list of Class 2 devices from 510(k) requirements, subject to certain limitations.

Human Drugs

CGMP Violations at Stason Pharmaceuticals

FDA warns Stason Pharmaceuticals about CGMP violations in its production of finished drugs.

Human Drugs

CGMP Deviations at Mexican Signa Facility

FDA warns Canadas Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.

Centurion Medical Products Kit Issues

FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile convenience kits.