An FDA inspection at Lonzas Viral Vector contract-manufacturing facility leads to a four-item FDA-483 and resumption of the agencys review of a Bristo...
FDA alerts health care professionals about labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents, to warn about intr...
The incoming Biden Administration chooses former FDA commissioner David Kessler stration to lead the U.S. Covid-19 vaccination efforts replacing Oper...
FDA Webviews newsroom closes Monday (1/18) in observance of Martin Luther King day.
FDA announces an indictment (XXX DELETE XXX)charging two former Michigan-based Beaumont Hospital employees and a medical supply distributor with wire ...
Two Hyman Phelps attorneys analyze provisions of the Orange Book Modernization Act signed into law earlier this month.
FDA issues a pandemic guidance easing enforcement against some modifications to coagulation systems.
Federal Register notice: FDA withdraws approval of 27 ANDAs from multiple applicants because the products are no longer marketed.