[ Price : $8.95]
FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs El...[ Price : $8.95]
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.[ Price : $8.95]
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.[ Price : $8.95]
The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management mat...[ Price : $8.95]
Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan d...[ Price : $8.95]
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.[ Price : $8.95]
FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (...