FDA approves an Akorn ANDA for a generic copy of Bausch & Lombs Lotemax (loteprednol etabonate) ophthalmic suspension, 0.5%.
FDA clears a Medicrea Group 510(k) for expanded use of its proprietary surgical planning software, UNiD Hub.
Federal Register notice: FDA extends the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products.
Federal Register notice: FDA corrects a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products.
Federal Register notice: FDA seeks comments on an information collection extension for Abbreviated New Animal Drug Applications Sections 512(b)(2) an...
Federal Register notice: FDA determines that Cephalons Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for safety or effectiveness re...
FDA issues a draft guidance on information to include in premarket submissions and applications for medical devices with quantitative imaging function...
FDA publishes a draft guidance to assist in development of bispecific antibodies.