FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Latest Potential Signals of Serious Drug Risks

FDA posts the latest three months of potential signals of serious risks/new safety information for prescription drug products.

latest-news-card-1
Human Drugs

Drug Companies Expected to Hike Prices

Reuters reports that several major drug companies are expected to raise list prices on some 350 drugs this month.

latest-news-card-1
Medical Devices

Vivos Gets Sleep Apnea Device Cleared

FDA clears a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea and snoring in adults.

latest-news-card-1
Human Drugs

Consider Oncology Single-Arm Trial Issues: CDER

CDER researchers discuss some of the challenges in using single-arm trials to support the approval of oncology drugs.

latest-news-card-1
Medical Devices

Medical Device Consensus Standards Database Updated

FDA updates the CDRH Recognized Consensus Standards database, adding List 59.

latest-news-card-1
Human Drugs

FDA Changes Mifepristone REMS

FDA modifies the mifepristone REMS to remove the in-person dispensing requirement and permit dispensing by certified pharmacies.

latest-news-card-1
FDA General

FDA Reforms Included in Year-end Omnibus Bill

In addition to a $226 million boost in FDA spending levels, the year-end omnibus spending bill also includes notable agency reforms that were once par...

latest-news-card-1
Human Drugs

Accord Healthcare Recalls 2 Daptomycin Products

FDA says Accord Healthcare recalled one lot of daptomycin for injection due to a labeling mix-up.

latest-news-card-1
Human Drugs

FDA Approves Acers Olpruva for Urea Cycle Disorders

FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.

latest-news-card-1

FTC Updates Health Products Compliance Guide

Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many additional health-relate...