[Federal Register Volume 65, Number 47 (Thursday, March 9, 2000)]
[Notices]
[Page 12556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-0835]
Draft Guidance for Industry on Conjugated Estrogens, USP: LC-MS
Method for Both Qualitative Chemical Characterization and Documentation
of Qualitative Pharmaceutical Equivalence; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Conjugated
Estrogens, USP: LC-MS Method for Both Qualitative Chemical
Characterization and Documentation of Qualitative Pharmaceutical
Equivalence.'' This draft guidance is intended to provide
recommendations to applicants who wish to submit a new drug application
or abbreviated new drug application for a natural source conjugated
estrogens solid oral dosage form. This guidance provides a description
of the liquid chromatography-mass spectrometry (LC-MS) method that can
be used to address both qualitative chemical characterization and
qualitative pharmaceutical equivalence (PE).
DATES: Submit written comments on the draft guidance by June 8, 2000.
General comments on agency guidance documents are welcome at any time.
ADDRESSES: Copies of this draft guidance for industry are available on
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit
written requests for single copies of the draft guidance to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Wallace P. Adams, Center for Drug
Evaluation and Research (HFD-350), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5651.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Conjugated Estrogens, USP: LC-MS
Method for Both Qualitative Chemical Characterization and Documentation
of Qualitative Pharmaceutical Equivalence.'' Chemical characterization
and PE of natural source conjugated estrogens involve both qualitative
and quantitative aspects. Qualitative aspects of both chemical
characterization and PE involve detection and measurement of certain of
the components in conjugated estrogens. The recommended methodology,
LC-MS, is applicable to both the drug substance and/or solid oral
dosage forms. This draft guidance provides a description of the LC-MS
method developed by the Division of Testing and Applied Analytical
Development/Office of Pharmaceutical Science/Center for Drug Evaluation
and Research for both the qualitative chemical characterization and
documentation of qualitative PE of natural source conjugated estrogens.
Interpretation of the data for PE is beyond the scope of this guidance
and will be addressed in a separate document. Quantitative aspects of
chemical characterization and PE use the gas chromotography (GC)
(flame-ionization detector) and high-pressure liquid chromotography
(HPLC) (ultraviolet detector) assays described in a draft proposed
Conjugated Estrogens, USP, monograph (http://www.fda.gov/cder/drug/
monographs/default.htm), and they are not the subject of this guidance.
This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on this LC-MS method
for both qualitative chemical characterization and documentation of
qualitative pharmaceutical equivalence of conjugated estrogens, USP. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes,
regulations, or both.
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft guidance. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The draft guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 1, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5751 Filed 3-6-00; 2:58 pm]
BILLING CODE 4160-01-F