Federal Register notice: FDA submits to OMB an information collection extension for Abbreviated New Animal Drug Applications.
Canadian health professor Matthew Herder says FDAs power to withdraw a drug if its manufacturer fails to produce useful required post-approval studies...
FDA warns Stemell about multiple violations in its production of umbilical cord and umbilical cord blood products.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Millennium Pharmaceuticals Bevyxxa (betrixaban ...
CDER deputy center director for clinical science Robert Temple discusses the move by industry and the agency to the third age of drug development the...
Federal Register notice: FDA extends the comment period for an 8/2 notice on a draft guidance on testing and labeling medical devices for MRI safety.
FDA warns Chinas Yino, Inc., about significant CGMP deviations in its manufacturing of APIs.
FDA releases a summary of changes to seven REMS shown on the REMS Web site in July and August.