Federal Register notice: FDA makes available a draft guidance entitled Transdermal and Topical Delivery Systems Product Development and Quality Consi...
Federal Register notice: FDA sends to OMB a proposed information collection on Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United Sta...
Federal Register notice: FDA sends to OMB an information collection extension for its Guidance for Industry on Dear Health Care Provider Letters: Impr...
FDA releases FDA-483s from inspections at two Aurobindo units in India.
FDA works with Australia and Canada to approve a new indication for AstraZenecas Calquence.
Washington Legal Foundation says the DC Court of Appeals should uphold a decision barring HHS from requiring drug companies to include a drugs list pr...
A new report by the National Academy of Sciences recommends that regulators like FDA need to make increased use of reliance and cooperation with other...
FDA clears a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interf...