[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Notices]
[Pages 66191-66192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4718]
Guidance for Industry on In Vivo Drug Metabolism/Drug Interaction
Studies--Study Design, Data Analysis, and Recommendations for Dosing
and Labeling; 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 guidance for industry entitled ``In Vivo Drug
Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and
Recommendations for Dosing and Labeling.'' This guidance provides
recommendations to sponsors of new drug applications (NDA's) and
biologics license applications (BLA's) for therapeutic biologics on
carrying out in vivo drug metabolism and metabolic drug-drug
interaction studies. The guidance reflects the agency's current view
that the metabolism of a new drug should be defined during drug
development and that its interactions with other drugs should be
explored as part of an adequate assessment of the safety and
effectiveness of the drug.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857; or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research (CBER), 1401 Rockville Pike,
[[Page 66192]]
Rockville, MD 20852-1448, FAX: 888-CBERFAX or 301-827-3844. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit written comments on the guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Shiew-Mei Huang, Center for Drug
Evaluation and Research (HFD-850), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5671; or David Green, Center
for Biologics Evaluation and Research (HFM-579), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5349.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``In Vivo Drug Metabolism/Drug Interaction Studies--Study
Design, Data Analysis, and Recommendations for Dosing and Labeling.'' A
draft of this guidance was published for comment in the Federal
Register of November 19, 1998 (63 FR 64269). The guidance has been
revised after careful consideration of public comments received between
November 1998 and March 1999.
Previous guidance from FDA on the use of in vitro approaches to
study metabolism and metabolic drug-drug interactions is available in a
document entitled ``Drug Metabolism/Drug Interaction Studies in the
Drug Development Process: Studies In Vitro'' (April 1997). This
guidance should be viewed as a companion to this earlier guidance. The
earlier guidance addressed techniques and approaches for in vitro
studies of drug metabolism and drug interactions and the correlation
between in vitro and in vivo studies. This guidance discusses study
design, choice of interacting drugs, and data analysis and provides
recommendations for dosing and labeling.
This Level 1 guidance document is being issued consistent with
FDA's good guidance practices (62 FR 8961, February 27, 1997). It
represents the agency's current thinking on drug metabolism and drug-
drug interactions. 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, regulations, or both.
II. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. 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 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
Copies of this guidance for industry are available on the Internet
at http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/
cber/guidelines.htm.
Dated: November 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Poilcy.
[FR Doc. 99-30568 Filed 11-23-99; 8:45 am]
BILLING CODE 4160-01-F