Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB.
American Gene Technologies files an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy being developed for el...
FDA says Johnson & Johnson has recalled one lot of its Johnsons Baby Powder (Lot #22318RB) after an agency sample detected asbestos.
Nuvectra submits FDA-requested data to allow the agency to complete its review of a 2017-submitted PMA for Virtis for treating chronic urinary retenti...
FDA has approved a Teligent ANDA for Gentamicin Sulfate Cream USP, 0.1%. The drug is used to treat minor skin infections (such as impetigo, folliculit...
AdvaMed CEO Scott Whitaker asks President Trump to support permanent elimination of the medical device excise tax that is set to return 1/1/20.
Federal Register notice: FDA announces that it is accepting invitations to participate in the Fiscal Year 2020 CDER Office of Pharmaceutical Quality S...