FDA approves a Janssen supplemental BLA for tremfya (guselkumab) for adult patients with active psoriatic arthritis.
FDA says commissioner Stephen Hahn will kick off a 7/21 virtual public meeting on GDUFA 3 reauthorization.
FDA issues a guidance on electronic formats for medical device regulatory submissions.
Federal Register notice: FDA announces the revocation of an Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Covid19 IgM/I...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Guidance for the Non-Clinical and Clinical Investigation of ...
Federal Register notice: FDA announces its support for the current version of Clinical Data Interchange Standards Consortium Standard for the Exchange...
FDA issues a guidance recommending ways to comply with the clinical testing special control for 510(k)s for prostate ablation high-intensity ultrasoun...
Federal Register notice: FDA makes information available on the issuance and reissuance of Emergency Use Authorizations for certain medical devices re...