[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5671]
[[Page Unknown]]
[Federal Register: March 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0049]
Clinical Trial Design Issues of Liposomal Antifungal Agents;
Public Workshop
AGENCY: Food and Drug Administration and National Institute of Allergy
and Infectious Diseases, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) in conjunction with the
National Institute of Allergy and Infectious Diseases (NIAID) is
announcing a public workshop on clinical trial design issues of
liposomal antifungal agents. The workshop will enable experts in the
field of fungal diseases to exchange ideas regarding clinical trials of
liposomal antifungal agents. While the workshop is not intended to
result in consensus among the participants or formulation of agency
policy, discussions regarding these agents may provide assistance to
pharmaceutical sponsors in designing appropriate study protocols and
expediting drug development.
DATES: The public workshop will be held on Wednesday, April 20, 1994,
from 1 p.m. to 5 p.m. Submit written notices of participation and
comments by March 25, 1994. Registration must be received by March 25,
1994. Written comments will be accepted until June 3, 1994.
ADDRESSES: The public workshop will be held at the Parklawn Bldg.,
conference rm. G, 5600 Fishers Lane, Rockville, MD 20857. Submit
written notices of participation and comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420
Parklawn Dr., Rockville, MD 20857. 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. A transcript and summary of the workshop will be
available from the Dockets Management Branch (address above).
FOR FURTHER INFORMATION CONTACT: Cathy E. Hobbs, Center for Drug
Evaluation and Research (HFD-530), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-9550.
Those persons interested in attending this meeting should FAX their
registration to 301-443-9292, including name, firm name, address, and
telephone number. There is no registration fee for this workshop, but
advance registration is required. Interested parties are encouraged to
register early because space is limited.
SUPPLEMENTARY INFORMATION: Liposomal drugs are drugs that use a new
drug-delivery system that incorporates the drug by either encapsulating
it with liposomes or by forming a complex with lipid molecules. Drug
delivery by this technique has potential advantages over the parent
drug alone in specific tissue targeting and in improved toxicity
profiles. Liposomal drugs are considered pharmacokinetically and
pharmacodynamically different from the parent drug.
The public workshop will focus on designing clinical trials for
liposomal drugs. Issues for discussion include whether and how to
conduct active-controlled trials of the liposomal drug, taking into
consideration the specific drug and fungal infection, and whether the
use of historical controls might be justified in some cases and, if so,
how historical control data might be collected for specific fungal
infections.
The workshop will begin with presentations by FDA and an industry
representative, followed by a panel discussion. FDA and NIAID staff
members will cochair the panel. The final part of the workshop will be
devoted to questions for panel members.
A transcript and summary of the workshop will be available from the
Freedom of Information Office (HFI-35) Food and Drug Administration
5600 Fishers Lane Rockville, MD 20857, approximately 10 business days
after the workshop at a cost of 10 cents per page.
Interested persons may submit comments on the workshop to the
Dockets Management Branch (address above). 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. Received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
To permit time for all interested persons to submit data,
information, or views on this subject, the administrative record of the
workshop will remain open until June 3, 1994. Persons who wish to
provide additional materials for consideration should file these
materials with the Dockets Management Branch (address above) by June 3,
1994.
Dated: March 7, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-5671 Filed 3-10-94; 8:45 am]
BILLING CODE 4160-01-F
