A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act liability for life s...
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.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 launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.
FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs Eliquis with a higher ...
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.
