The Association for the Advancement of Medical Instrumentation publishes consensus guidelines for implementing remote control for many critical medica...
Federal Register notice: FDA sends to OMB an information collection extension for Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR ...
Federal Register notice: FDA sends to OMB an information collection extension for Electronic Records; Electronic Signatures 21 CFR Part 11.
Federal Register notice: FDA reopens the comment period for a 5/31/2019 notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immed...
FDA warns dietary supplement manufacturer ForYou, Inc., about CGMP and other violations in its production and distribution of dietary supplements.
The Medical Device Innovation Consortium says it has launched a stakeholder working group to address 5G-enabled healthcare technologies.
FDA approves Gallium 68 PSMA-11 for use in PET imaging of prostate-specific membrane antigen in men with prostate cancer.
FDA warns Industry Lab Diagnostic Partners that it is distributing an unapproved home Covid-19 test kit.