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FDA, ATA, The Endocrine Society, AACE sponsor workshop on bioequivalence

[Federal Register: April 20, 2005 (Volume 70, Number 75)]
[Notices]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0137]

Levothyroxine Sodium Therapeutic Equivalence; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting on the therapeutic equivalence of levothyroxine sodium drug products. This will be a workshop involving FDA staff and representatives of three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). The purpose of the public meeting is to discuss FDA's regulatory standards and methodological approaches for determining therapeutic equivalence between levothyroxine sodium drug products. The agency is seeking comments and input from interested constituencies, including patient advocacy and education groups, and pharmaceutical sponsors.

DATES: The public meeting will be held on May 23, 2005, from 8:30 a.m. to 5 p.m.

Dr. Lawrence Wood, Medical Director of the Thyroid Foundation has been invited to attend the meeting as a representative of thyroid patients and will report on the TFA survey of patients who had their thyroid prescriptions changed as a result of the FDA ruling...As shown in the survey results most patients did not feel well after the change and the majority had abnormal TSH results when they were retested on the new thyroxine preparations.

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