Daily Archives: January 6, 2009

A Conversation with the FDA About the Nature of REMS

Posted on January 6, 2009 by Mark Senak

  In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush.  The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was … Continue reading →

Posted in FDA Policy, Risk Management | 2 Comments