CDERs Office of Prescription Drug Promotion no longer maintains an aggregated Web page of recent Warning Letters and Untitled Letters issued to drug m...
Genentech says it is withdrawing the U.S. accelerated-approved indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial...
FDA clears a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with single-sided deafness...
Federal Register notice: CDER announces that beginning 3/15 it will support version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC)S...
Federal Register notice: FDA seeks comments on an information collection entitled Generic Clearance for the Collection of Quantitative Data on Tobacco...
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no l...
Federal Register notice: FDA sends to OMB an information collection entitled Study of Multiple Indications in Direct- to-Consumer Television Advertise...
FDA issues a device safety alert on thermal imaging systems intended to measure human body temperature because improper use could provide inaccurate t...