Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many additional health-relate...
FDA warns Hanover, PA-based MD Pharmaceutical Supply about CGMP deviations in its drug repackaging and relabeling operations.
FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.
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...
