FDA approves changes to the prescribing information for Pfizers Chantix (varenicline) that specifies that the drug is not recommended for pediatric pa...
FDA warns American Preclinical Services about violations in its conduct of several nonclinical medical device laboratory services.
FDA clears an Intuitive Surgical 510(k) for the Ion endoluminal system to enable minimally invasive biopsies in the peripheral lung.
FDA releases a draft guidance on Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.
FDA clears an Axilum Robotics 510(k) for the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the MagVenture Transcranial Mag...
FDA opens for comment a new proposed rule on regulatory requirements for most sunscreen products in the U.S.
The Justice Department says four companies and three individuals pleaded guilty to charges arising from the illegal importation and sale of erectile d...
FDA issues a guidance describing PMA acceptance and filing requirements to make the process more efficient.