[ 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AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.[ Price : $8.95]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 launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.[ 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]
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsore...[ Price : $8.95]
FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.