Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Registration of Human Drug Compounding Outsour...
Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Fees for Human Drug Compounding Outsourcing Fa...
Federal Register notice: FDA corrects a 9/21 Federal Register notice that announced the withdrawal of approval of 27 abbreviated new drug applications...
Federal Register notice: FDA makes available a draft guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GD...
FDA appears to be backing the approval of Novo Nordisks Glucagon-like peptide-1 (GLP-1) diabetes drug semaglutide as it heads for an advisory committe...
FDA clears a Stryker 510(k) for its cementless Mako Total Knee with Triathlon Tritanium.
FDA clears a NuVasive 510(k) for the TLX interbody system for use in spinal fusion surgery.
FDA Review posts the Federal Register notices for the week ending 10/13/2017.