Pew Charitable Trusts public health director Elizabeth Jungman says progress has been made under the Drug Quality and Security Act but full implementa...
FDA officials announce a new committee to consider changes to reviewing and approving nicotine replacement therapy products.
Attorney Michelle Yeary says a Tennessee federal court dismissed many parts of a failure-to-warn case against Boehringer Ingelheim over injuries alleg...
FDA issues a draft guidance leveraging its experience in implementing the MDUFA 3 Dual 5120(k) and CLIA Waiver by Application pathway.
FDA warns South Koreas Dae Young Foods Company about CGMP and misbranding violations in its work as a contractor manufacturing finished pharmaceutical...
CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the ways in which the agencys Sentinel System is being used and can...
A Public Citizen analysis of 457 rulemakings withdrawn by the Trump administration finds that 26 were from FDA, the highest number of any HHS agency.
FDA posts a draft guidance on Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for...