On February 25, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend the GcP regulations as the agency seeks to extend control over international trials at the same time tightening requirements for trials in the USA.
Archives for April 2013
FDA has publsihed for comment a new Draft Guidance on application of ISO 10993. This Guidance is intended to replace the 1995 “Blue Book Memo” G95-1.
Are you aware that an “order here” message on your website may get you into trouble in Taiwan?