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...
FDA describes two new issues that have occurred in some reworked Philips Respironics Trilogy 100 and 200 ventilators.
Retired FDA top cop Catherine Hermsen says there is a need to expand collaboration with regulators in other countries to combat international criminal...
Reactions to a Congressional report on FDAs 2021 controversial review and approval of Biogens Alzheimers drug Aduhelm sharply criticize the approval a...
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.
President Biden signs into law FDAs fiscal year 2023 spending bill as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations A...