FDA revises the Plan B One-Step information sheet to clarify the emergency contraceptive cannot be used to cause an abortion of an existing pregnancy.
An Oklahoma federal court issues a consent decree against the Qualgen drug compounding facility and two of its principals.
Two Hyman, Phelps & McNamara attorneys say FDA succeeded in having Congress use the recent omnibus spending bill to allow it to ban some individual us...
Attorney Heidi Gertner explains how FDA is pushing for a voluntary Rx to OTC switch of naloxone drug products.
FDA publishes a guidance recommending that applicants change the labeling for antihypertensives to include standard language on the cardiovascular ben...
CDER Office of Prescription Drug Promotion researchers look for the most effective way to communicate risk information in character space limited comm...
FDA warns La Palma, CA-based Adarsh Daswani about issues in his work conducting a clinical investigation of an investigational drug.
FDA warns DuPont Nutrition USA about CGMP deviations in its manufacturing of the widely-used drug excipient Avicel.
