FDA

Almost like clockwork, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has released its…

2015 could prove to be a significant year for how the Food and Drug Administration approaches drug companies’ off-label speech.…

Yesterday, the Food and Drug Administration (FDA) announced the filing of a consent decree with Medtronic and two…

The 2015 FDLI Annual Conference kicked off yesterday in Washington, DC. The conference hosted a variety of impressive…

The Food and Drug Administration last week finalized two guidances intended to speed the process of getting innovative…

Consumer advocacy group Public Citizen is calling on the Food and Drug Administration (FDA) to “stop the apparently violative…

The first U.S. biosimilar is one step closer to entering the marketplace. Last week, U.S. District Judge Richard Seeborg…

Today, the Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. …

Recognizing that drug companies would actually incur a financial loss in developing important drugs for rare conditions,…

Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim,…