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
fda-device · Food and Drug Administration · Rule · Published 1999-03-09 · 64 FR 11376
Document
Document number
99-5681
Federal Register citation
64 FR 11376
CFR reference
21 CFR 26
Type
Rule
Action
Establishment of a public docket and FDA contact points.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-03-09
HHS docket
Docket No. 98S-1064
Abstract
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.