[Federal Register: August 12, 2005 (Volume 70, Number 155)]
[Notices]               
[Page 47217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au05-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-0835]

 
Draft Guidance for Industry on Conjugated Estrogens, USP-LC-MS 
Method for Both Qualitative Chemical Characterization and Documentation 
of Qualitative Pharmaceutical Equivalence; Withdrawal of Guidance

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; withdrawal.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance for industry entitled ``Conjugated 
Estrogens, USP-LC-MS Method for Both Qualitative Chemical 
Characterization and Documentation of Qualitative Pharmaceutical 
Equivalence.'' FDA is withdrawing the draft guidance because the 
published methodology limits the submission of scientifically valid 
information to the agency that may be based on different methodologies. 
FDA does not want to dictate the scientific approach for developing 
adequate methods.

FOR FURTHER INFORMATION CONTACT:  David J. Cummings, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5187.

SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of a draft 
guidance for industry entitled ``Conjugated Estrogens, USP-LC-MS Method 
for Both Qualitative Chemical Characterization and Documentation of 
Qualitative Pharmaceutical Equivalence.'' The agency announced the 
availability of the guidance in the Federal Register of March 9, 2000 
(65 FR 12556). The draft guidance was originally intended to provide 
recommendations to applicants on how to use the liquid chromatography 
mass spectrometry (LC-MS) method to address both qualitative chemical 
characterization and qualitative pharmaceutical equivalence for natural 
source conjugated estrogens. FDA is withdrawing the guidance because 
advances in technology allow for the possibility of using different 
methodologies. FDA does not want to inhibit companies from using a 
methodology that might provide additional scientific data to support 
characterization and pharmaceutical equivalence for conjugated 
estrogens in the future. If submitted, these data would be evaluated to 
determine applicability of the method before an application could be 
approved.

    Dated: August 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16019 Filed 8-11-05; 8:45 am]

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