[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Pages 67879-67880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration
[Docket No. 97D-0483]


Draft Guidance for Industry on Food-Effect Bioavailability and 
Bioequivalence Studies; 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availability of a draft guidance for industry entitled ``Food-Effect 
Bioavailability and Bioequivalence Studies.'' The draft guidance is 
intended for sponsors of new drug applications (NDA's), abbreviated new 
drug applications (ANDA's) and abbreviated antibiotic applications 
(AADA's) who intend to conduct food-effect bioavailability (BA) and 
bioequivalence (BE) studies for oral immediate release and modified 
release dosage forms. The guidance provides information and 
recommendations on study design, data analysis, and labeling.

DATES: Written comments may be submitted on the draft guidance by March 
2, 1998. General comments on the agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies ``Food-Effect 
Bioavailability and Bioequivalence Studies'' 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 guidance document to the 
Dockets Management Branch (HFD-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Ameeta Parekh, Center for Drug 
Evaluation and Research (HFD-860), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5325.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Food-Effect Bioavailability and 
Bioequivalence Studies.'' The draft guidance is intended to help 
sponsors of NDA's, ANDA's, and AADA's when conducting BA and BE studies 
with food for oral immediate release and modified release dosage forms.
    The intake of food is known to alter gastrointestinal physiology, 
generally delaying gastric emptying, stimulating bile flow, altering 
the pH of gastric environment and the blood flow to the region. These 
factors can influence the BA (important in new drug and formulation 
situations) and BE (important in switchability of drug products) when 
drug products are coadministered with food. Food also may alter lumenal 
metabolism and can

[[Page 67880]]

physically or chemically interact with a drug substance. Altered BA of 
drug products can lead to dosage adjustments or, more commonly, to the 
provision of specific dosing instructions in relation to administration 
with meals. This draft guidance provides a general design for and 
recommends ways this information can be appropriately addressed in the 
labeling.
    The draft guidance recommends that a food-effect assessment should 
be made early in drug development. It also recommends that subsequent 
studies following formulation changes may be eliminated provided that 
there is basis for assuming that the food-effect arises due to drug 
substance rather than formulation factors.
    This draft guidance addresses situations when food-effect BA and BE 
studies should be considered and when these may not be important. It 
examines study considerations, such as general design, subject 
selection, formulation selection, test meal, treatment administration, 
sample collection, and data analysis. It also addresses issues related 
to labeling for food effects.
    This draft guidance document represents the agency's current 
thinking on food-effect bioavailability and bioequivalence studies. 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 statute, 
regulations, or both.
    Interested persons may submit written comments on the draft 
guidance document 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. The draft guidance 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.
    An electronic version of this guidance is available on the World 
Wide Web at http://www.fda.gov/cder/guidance/index.htm.

    Dated: December 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33802 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F