80 FR 26058 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 87 (May 6, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics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 for sponsors of investigational new drug applications (INDs), and applicants that submit new drug applications, abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of in vivo bioavailability (BA) and/or bioequivalence (BE) studies.

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26058-26059]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1245]


Waiver of In Vivo Bioavailability and Bioequivalence Studies for 
Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics 
Classification System; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Waiver of In 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 for sponsors of 
investigational new drug applications (INDs), and applicants that 
submit new drug applications, abbreviated new drug applications 
(ANDAs), and supplements to these applications for immediate-release 
(IR) solid oral dosage forms, and who wish to request a waiver of in 
vivo bioavailability (BA) and/or bioequivalence (BE) studies.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 6, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

[[Page 26059]]

    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-1573.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 for sponsors and applicants who wish to request a 
waiver of in vivo BA and/or BE studies for IR solid oral dosage forms. 
These waivers are intended to apply to: (1) Subsequent in vivo BA or BE 
studies of formulations after the initial establishment of the in vivo 
BA of IR dosage forms during the IND period and (2) in vivo BE studies 
of IR dosage forms in ANDAs.
    Regulations at 21 CFR part 320 address the requirements for BA and 
BE data for approval of drug applications and supplemental 
applications. Provision for waivers of in vivo BA/BE studies 
(biowaivers) under certain conditions is provided at Sec.  320.22. This 
guidance updates the 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,'' 
published in August 2000, and explains when biowaivers can be requested 
for IR solid oral dosage forms based on an approach termed the 
Biopharmaceutics Classification System (BCS). This guidance includes 
biowaiver extension to BCS class 3 drug products and additional 
modifications, such as criteria for high permeability and high 
solubility.
    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 FDA's current thinking on waiver of in vivo 
bioavailability and bioequivalence studies for immediate-release solid 
oral dosage forms based on a BCS. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314, including 
Sec. Sec.  314.50 and 314.94, have been approved under OMB control 
number 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10479 Filed 5-5-15; 8:45 am]
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