[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]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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