[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Notices]
[Page 53019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1434]


Guidance for Industry on Waiver of In Vivo Bioavailability and 
Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms 
Based on a Biopharmaceutics Classification System; 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 ``Waiver of In Vivo 
Bioavailability and Bioequivalence Studies for Immediate Release Solid 
Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' 
The guidance provides recommendations to sponsors of investigational 
new drug applications (IND's), new drug applications (NDA's), 
abbreviated new drug applications (ANDA's), and supplements to these 
applications who wish to request a waiver of in vivo bioavailability 
(BA) and bioequivalence (BE) studies for immediate-release solid oral 
dosage forms.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of this guidance 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 to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mei-Ling Chen, Center for Drug 
Evaluation and Research (HFD-350), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5688.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Waiver of In Vivo Bioavailability and 
Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms 
Based on a Biopharmaceutics Classification System.'' This guidance 
provides recommendations on when in vivo BA/BE studies may be waived 
for IND's, NDA's, and ANDA's during either the pre- or postapproval 
period.
    Although in vivo documentation of BA and BE has been required for 
many drug products, in some cases FDA has allowed the use of in vitro 
methods for documenting BA and BE. As noted both at 21 CFR 320.22, 
``Criteria for Waiver of Evidence of In Vivo Bioavailability or 
Bioequivalence,'' and at 21 CFR 320.24, ``Types of Evidence to 
Establish Bioavailability or Bioequivalence,'' many options exist to 
allow demonstration of BA and BE through in vitro methods. This 
guidance describes recommendations for requesting waivers of in vivo 
BA/BE studies on the basis of the solubility and intestinal 
permeability of the drug substance and dissolution characteristics of 
the drug product, based on a biopharmaceutics classification system.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance 
represents the agency's current thinking on the waiver of in vivo BA 
and BE studies for immediate-release solid oral dosage forms based on a 
biopharmaceutics classification system. 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 an approach 
satisfies the requirements of the applicable statutes, regulations, or 
both.
    Interested persons may, at any time, submit written comments on the 
guidance 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 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.

    Dated: August 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-22225 Filed 8-30-00; 8:45 am]
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