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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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