FDA commissioner Stephen Hahn says the agency is posting scientific review materials relating to emergency use authorization actions taken by FDA, as ...
PhRMA adds a chapter on diversity to its principles for conducting and communicating clinical trials.
FDA posts new drug safety-related labeling changes for five biologics.
FDA warns Family Pharmacy of Statesville, NC, about multiple drug compounding violations.
FDA issues a final guidance on Certificates of Confidentiality, which describes the agencys implementation of revised provisions under the 21st Centur...
Alkermes says it is working with FDA on issues raised in an agency complete response letter for the firms NDA for ALKS 3831 to treat schizophrenia and...
CDER deputy Center director for clinical science Bob Temple opines on meetings with industry on product development issues that may be suffering from ...
FDA releases its latest batch of Warning Letters that include Family Pharmacy and Quten Research Institute.