[Federal Register: November 24, 1999 (Volume 64, Number 226)]
[Notices]               
[Page 66191-66192]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no99-76]                         

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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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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