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2010-09-23
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Exocrine Pancreatic Insufficiency Drug Products
Part VI
Notices
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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 that all exocrine pancreatic insufficiency drug products are new drugs and is announcing the conditions for continued marketing of these drug products. Manufacturers who wish to continue to market exocrine pancreatic insufficiency drug products must submit new drug applications (NDAs); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that prescription exocrine pancreatic insufficiency drug products are medically necessary and, accordingly, is allowing manufacturers 4 years to obtain approved applications.
69 FR 23410
https://www.govinfo.gov/app/details/FR-2004-04-28/04-9652
04-9652
fr28ap04-107
4160-01-S
Docket No. 2003N-0205
https://www.govinfo.gov/app/details/FR-2004-04-28/04-9652
https://www.govinfo.gov/content/pkg/FR-2004-04-28/html/04-9652.htm
https://www.govinfo.gov/content/pkg/FR-2004-04-28/pdf/04-9652.pdf
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69 FR 23410
Exocrine Pancreatic Insufficiency Drug Products; Federal Register Vol. 69, Issue
NOTICE
04-9652
VI
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2004-04-28
Docket No. 2003N-0205
4160-01-S
04-9652
Notice.
The Food and Drug Administration (FDA) is announcing that all exocrine pancreatic insufficiency drug products are new drugs and is announcing the conditions for continued marketing of these drug products. Manufacturers who wish to continue to market exocrine pancreatic insufficiency drug products must submit new drug applications (NDAs); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that prescription exocrine pancreatic insufficiency drug products are medically necessary and, accordingly, is allowing manufacturers 4 years to obtain approved applications.
This notice is effective April 28, 2004.
Mary E. Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
Human drugs:
Exocrine pancreatic insufficiency drug products; new drug application requirements,
Federal Register
Vol. 69, no. 82
Office of the Federal Register, National Archives and Records Administration
2004-04-28
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