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2010-09-23
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Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient
Notices
D09002ee1bde83dd6
D09002ee1bde83e37
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Saccharomyces boulardii (S. boulardii), 250 milligrams (mg) (4.5 x 10\9\ lyophilized, viable yeast cells) taken 1 to 2 times daily with a maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in capsule form as an antidiarrheal ingredient. FDA has reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/ E) for its proposed OTC use.
69 FR 51852
https://www.govinfo.gov/app/details/FR-2004-08-23/04-19180
04-19180
fr23au04-52
4160-01-S
Docket No. 2004N-0346
https://www.govinfo.gov/app/details/FR-2004-08-23/04-19180
https://www.govinfo.gov/content/pkg/FR-2004-08-23/html/04-19180.htm
https://www.govinfo.gov/content/pkg/FR-2004-08-23/pdf/04-19180.pdf
2 p.
51852
51853
69 FR 51852
Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient; Federal Register Vol. 69, Issue
NOTICE
04-19180
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2004-11-22
Docket No. 2004N-0346
4160-01-S
04-19180
Notice of eligibility; request for data and information.
The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Saccharomyces boulardii (S. boulardii), 250 milligrams (mg) (4.5 x 10\9\ lyophilized, viable yeast cells) taken 1 to 2 times daily with a maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in capsule form as an antidiarrheal ingredient. FDA has reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/ E) for its proposed OTC use.
Submit data, information, and general comments by November 22, 2004.
Michael L. Koenig, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
Human drugs:
Antidiarrheal ingredient (OTC); safety and efficacy review,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 69, no. 162
Office of the Federal Register, National Archives and Records Administration
2004-08-23
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daily
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194 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2004-08-23
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https://www.govinfo.gov/app/details/FR-2004-08-23
https://www.govinfo.gov/content/pkg/FR-2004-08-23/pdf/FR-2004-08-23.pdf
https://www.govinfo.gov/content/pkg/FR-2004-08-23/xml/FR-2004-08-23.xml
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2010-09-23
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FR-2004-08-23
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