FDA FDA Commissioner Margaret Hamburg To Resign in March, Writes Farewell… Thomas Sullivan Feb 5, 2015 0 Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), has resigned, and will leave the agency at…
BioSimilar Biosimilars: FDA Calls For Comment on Data Needed To Show a Product is… Thomas Sullivan Feb 5, 2015 0 2015 is poised to be a big year for biosimilars. For starters, FDA owes industry more guidance on “interchangeability” and the…
Uncategorized FDA Loses Orphan Drug Exclusivity Battle, But Doesn’t Plan To Change Its… Thomas Sullivan Feb 5, 2015 0 Earlier this year, we noted the Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since…