February 2015

Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), has resigned, and will leave the agency at…

2015 is poised to be a big year for biosimilars. For starters, FDA owes industry more guidance on “interchangeability” and the…

Earlier this year, we noted the Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since…

Late last year, the FDA released draft guidance for the pharmaceutical industry entitled "How to Obtain a Letter from FDA Stating…

Stringent conflicts-of-interest policies keep many experts off of FDA advisory committees. A new study suggests that the fear of…

The Centers for Medicare and Medicaid Services has announced that beginning today, February 2, 2015, applicable manufacturers and…

Last week, Dr. Murray Kopelow, president and CEO of the Accreditation Council for Continuing Medical Education (ACCME), offered…