Federal Register notice: FDA seeks comments on an information collection extension entitled Bar Code Label Requirement for Human Drug and Biological P...
FDA clears an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument.
FDA clears a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management.
Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.
Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Research.
A University of Toledo professor says FDA should stop clearing or approving reprocessing of pedicle screws and other implantable orthopedic devices.
FDA says SciGen is recalling specific lots of its irbesartan due to a potential for contamination.
CDERs Office of Prescription Drug Promotion warns Vanda about a Web page promoting its Fanapt and Hetlioz that doesnt contain any risk information abo...