Our Holiday Gift (or Torture) to Our Readers

Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer.  So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th.

To the tune of “Winter Wonderland,” this is “Winter Wonderland,

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency has struggled with evaluation of novel excipients in INDs,