AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.
The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management maturity program.
Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan drug ad price disclos...
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.
FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (difelikefalin acetat...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (trilaciclib), indicate...
Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.
