FDA releases a new guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the Covid-19 Publi...
Federal Register notice: FDA sends to OMB an information collection entitled Survey of Drug Product Manufacturing, Processing, and Packing Facilities ...
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.