[Federal Register: April 24, 2001 (Volume 66, Number 79)]
[Notices]
[Page 20665-20670]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Exchange of Letters Between the Food and Drug Administration and
Japan Concerning the Exchange of Certain Information on Pharmaceutical
Products
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, Department of Health and Human
Services, United States of America and the Inspection and Guidance
Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health
and Welfare, Japan. The parties concluded this exchange of letters on
December 27, 2000. These letters express the intentions of the United
States and Japan to exchange information on matters useful to
preserving the safety, quality, and efficacy of pharmaceutical products
in the markets of the United States and Japan.
DATES: Cooperation under the exchange of letters began December 27,
2000.
FOR FURTHER INFORMATION CONTACT: Joseph Famulare, Division of
Manufacturing and Product Quality (HFD-320), Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
7520 Standish Pl., Rockville, MD 20855, 301-827-0590.
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: April 11, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
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[FR Doc. 01-10017 Filed 4-23-01; 8:45 am]
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