[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20065]
[[Page Unknown]]
[Federal Register: August 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee Meeting; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Generic Drugs Advisory
Committee with Dermatologic Drugs Advisory Committee representation.
This meeting was announced in the Federal Register of July 27, 1994 (59
FR 38196). The amendment is being made to add an agenda item for
discussion on Tuesday, September 13, 1994. There are no other changes.
This amendment will be announced at the beginning of the open portion
of the meeting.
FOR FURTHER INFORMATION CONTACT: Kimberly L. Topper, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1994,
FDA announced that a meeting of the Generic Drugs Advisory Committee
with Dermatologic Drugs Advisory Committee representation would be held
on September 12 and 13, 1994. On page 38196, in the third column, under
Open committee discussion the agenda for the meeting is amended to read
as follows:
Open committee discussion. In April 1992, the Generic Drugs
Advisory Committee met to consider methods for documenting the
bioequivalence of topical corticosteriods. Subsequently, on July 1,
1992, the Office of Generic Drugs issued a guidance document entitled
``Interim Guidance for Topical Corticosteriods: In Vivo Bioequivalence
and in Vitro Release Methods.'' The purpose of the September 1994
meeting is to reexamine the 1992 interim guidance in light of new
experimental data and methods of analysis. On September 12, 1994, the
committee will discuss the pharmacodynamic (i.e., vasoconstrictor)
measurement of bioequivalence. On September 13, 1994, this topic will
be further discussed along with other issues related to the
documentation of equivalence according to the interim guidance.
Discussion will be limited to dermatologic products and will not
include ophthalmic or inhaled corticosteroid products. Pilot data will
be presented on the development of pharmacodynamic and pharmacokinetic
assays to demonstrate tretinoin bioequivalence. Also, on September 13,
1994, there will be a review of the current status of topics discussed
at previous Generic Drugs Advisory Committee meetings.
Dated: August 10, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-20065 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F
