[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Notices]
[Pages 75591-75600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-32005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-04-8002]


Exchange of Letters Between the Food and Drug Administration and 
the European Commission and the European Agency for the Evaluation of 
Medicinal Products Concerning the Sharing of Documents and/or 
Information Related to Assuring the Safety, Quality, and Efficacy of 
Pharmaceutical Products Intended for Human or Animal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
an exchange of letters between FDA and the European Commission and the 
European Agency for the Evaluation of Medicinal Products (EMEA). The 
participants concluded this exchange of letters on September 12, 2003. 
These letters express the intentions of FDA, the European Commission, 
and EMEA to continue cooperative activities to further enhance and 
strengthen communication between the respective organizations and 
further enhance public health promotion and protection in the European 
Union and the United States of America.

DATES: The agreement became effective September 12, 2003.

FOR FURTHER INFORMATION CONTACT: Michelle Limoli, European Commission 
Office of International Programs (HFG-1), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-0908.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and memoranda of understanding 
between FDA and others shall be published in the Federal Register, the 
agency is publishing notice of this exchange of letters.

    Dated: December 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 03-32005 Filed 12-30-03; 8:45 am]
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