[Federal Register: August 21, 2002 (Volume 67, Number 162)]
[Notices]               
[Page 54220]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au02-85]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0337]

 
Draft Guidance for Industry on Liposome Drug Products: Chemistry, 
Manufacturing, and Controls; Human Pharmacokinetics and 
Bioavailability; and Labeling Documentation; 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availability of a draft guidance for industry entitled ``Liposome Drug 
Products: Chemistry, Manufacturing, and Controls; Human 
Pharmacokinetics and Bioavailability; and Labeling Documentation.'' 
This guidance provides recommendations to applicants on the chemistry, 
manufacturing, and controls (CMC); human pharmacokinetics and 
bioavailability; and labeling documentation for liposome drug products 
submitted in new drug applications (NDAs).

DATES: Submit written or electronic comments on the draft guidance by 
November 19, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Liang Zhou, Center for Drug Evaluation 
and Research (HFD-180), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7471.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Liposome Drug Products: Chemistry, Manufacturing, and 
Controls; Human Pharmacokinetics and Bioavailability; and Labeling 
Documentation.''
    Liposome drug products are defined as drug products containing drug 
substances (active pharmaceutical ingredients) encapsulated in 
liposomes. A liposome is a microvesicle composed of a bilayer of lipid 
amphipathic molecules enclosing an aqueous compartment. Liposome drug 
products are formed when a liposome is used to encapsulate a drug 
substance within the lipid bilayer or in the interior aqueous space of 
the liposome. A drug substance in a liposome formulation is intended to 
exhibit a different pharmacokinetic and/or tissue distribution (PK/TD) 
profile from the same drug substance (or active moiety) in a 
nonliposomal formulation given by the same route of administration. The 
complete characterization of the PK/TD profile of a new liposome drug 
product is essential to establish the safe and effective dosing regimen 
of the product.
    The guidance provides recommendations to applicants on the CMC, 
human pharmacokinetics and bioavailability, and labeling documentation 
for liposome drug products submitted in NDAs. The guidance does not 
provide recommendations on: (1) Clinical efficacy and safety studies, 
(2) nonclinical pharmacology and/or toxicology studies, (3) 
bioequivalence studies or those to document sameness, (4) liposomal 
formulations of vaccine adjuvants or biologics, or (5) drug-lipid 
complexes.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on liposome 
drug products: CMC, human pharmacokinetics and bioavailability, and 
labeling documentation. 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 and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 13, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-21263 Filed 8-20-02; 8:45 am]
BILLING CODE 4160-01-S