In a Politico interview, new FDA commissioner Stephen Hahn stresses the importance of safety in drug importation and dietary supplement regulation.
FDA approves a Conturais PMA for Bulkamid for treating certain patients with stress urinary incontinence.
FDA approves an expanded label for Mercks insomnia drug Belsomra (suvorexant) C-IV to include findings on its use for treating insomnia in Alzheimers ...
CDRH issues its FY 2019 annual report for the Accreditation Scheme for Conformity Assessment program.
ML Strategies senior director Aaron Josephson predicts discussion topics likely to be included in upcoming negotiations to reauthorize FDA user fee pr...
FDA releases its latest batch of Warning Letters that includes Evig LLC and Won Industry Co.
FDA issues a coronavirus emergency use authorization to permit the wider use of a Centers for Disease Control and Prevention 2019-nCoV Real-Time RT-PC...
Federal Register notice: FDA submits to OMB an information collection extension for Planning for the Effects of High Absenteeism To Ensure Availabilit...