Implementation of the Mutual Recognition Agreement Between the United States and the European Community; Pharmaceutical GMP's and Medical Devices; Establishment of a Public Docket and FDA Contact Points

Streszczenie

The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site.