[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56718-56719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22309]
[[Page 56718]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1020]
Draft Guidance for Industry on Bioanalytical Method Validation;
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availability of a draft guidance for industry entitled ``Bioanalytical
Method Validation.'' The draft guidance is intended to provide
recommendations regarding analytical method development and validation
for the measurement of drugs and/or metabolites, therapeutic biologics,
and biomarkers for sponsors of investigational new drug applications
(INDs), new drug applications (NDAs), abbreviated new drug applications
(ANDAs), and biologics license applications (BLAs) for therapeutic
biologics regulated by the Center for Drug Evaluation and Research.
This draft guidance may apply to some studies related to the veterinary
drug approval process (Investigational New Animal Drugs (INADs), New
Animal Drug Applications (NADAs), and Abbreviated New Animal Drug
Applications (ANADAs)) regulated by the Center for Veterinary Medicine.
This guidance was originally issued in 2001. FDA is revising the
guidance to reflect advancements in the science and technology of
bioanalytical method validation.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 12, 2013.
ADDRESSES: Submit written requests for single copies of the revised
draft guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
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: Brian Booth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993-0002, 301-
796-1508; or John Kadavil, Center for Veterinary Medicine (HFV-151),
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,
240-276-9589.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Bioanalytical Method Validation.'' The measurement of drug
and/or metabolite, therapeutic biological product, or biomarker
concentrations in in vivo studies provides critical support for many
types of drug and therapeutic biologic development studies. The
accuracy and the reliability of these data are of critical importance
to the interpretation of the study outcomes. The draft guidance
reflects the Agency's view that the reliability of these data is, in
part, assured by adequate method development and validation prior to
study conduct. The method validation should provide assurance that the
samples are unaffected by handling conditions, and that the
measurements are accurate and can be repeated without significant
change.
The draft guidance provides recommendations for sponsors of INDs,
NDAs, ANDAs, and BLAs regarding measurement of drug, therapeutic
biological product, and biomarker concentrations in nonclinical and
clinical study samples. The guidance provides recommendations for
sponsors of INADs, NADAs, and ANADAs regarding measurement of drug
concentrations in some bioavailability, bioequivalence, and
pharmacokinetic studies. The guidance lists the recommendations for
sample handling and stability; method acceptance criteria for accuracy
and precision; and reproducibility. The guidance also addresses the
fit-for-purpose concept, biomarkers, and novel technologies.
On May 23, 2001 (66 FR 28526), FDA issued the first version of this
guidance. Since then, substantial scientific and technical advancements
have taken place related to the validation of bioanalytical methods.
FDA revised the guidance to reflect these advancements and is issuing
the revised guidance in draft to solicit public input. The revised
draft guidance contains a number of new sections, including sections on
endogenous compounds, incurred sample reanalysis, biomarker assays, use
of diagnostic kits and new technologies, system suitability, and
examples of report formats for tabular data listings. In addition, FDA
has updated sections where needed, such as the sections on
chromatography and ligand-binding assays. The changes and additions are
intended to reflect the many advances in the field during the last
decade.
This revised draft guidance is issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
Bioanalytical Method Validation. 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 requirement of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This revised draft 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 58
have been approved under OMB control number 0910-0119; the collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032; the collections of information in 21 CFR part 511
have been approved under OMB control number 0910-0117; and the
collections of information in section 360b(n)(1) (21 U.S.C 512(n)(1))
of the Federal Food, Drug and Cosmetic Act have been approved in OMB
control number 0910-0669.
III. 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
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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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances or http://www.regulations.gov.
Dated: September 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22309 Filed 9-12-13; 8:45 am]
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