REMS assessments found no cases of Torsades de pointes or unexplained sudden deaths among patients taking vandetanib during ...
The Food and Drug Administration has launched a new transparency policy for the reporting of foodborne illness outbreak ...
New tobacco products must submit a PMTA and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to ...
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies ...
U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday. Food ...
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