Source: https://regulations.justia.com/regulations/fedreg/2019/02/01/2019-00666.html
Timestamp: 2020-08-04 00:13:34
Document Index: 441003401

Matched Legal Cases: ['art 201', 'art 211', 'art 312', 'art 314', 'art 58', 'art 601', 'art 201', 'art 211', 'art 312', 'art 314', 'art 58', 'art 601']

Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability, 1163-1164 [2019-00666] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability, 1163-1164 [2019-00666]
Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability, 1163-1164 [2019-00666]
Download as PDF Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices and regulations. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.regulations.gov, https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. Dated: January 16, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–00681 Filed 1–31–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0539] Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Immunogenicity Testing of Therapeutic Protein Products— Developing and Validating Assays for Anti-Drug Antibody Detection.’’ This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance applies to assays for the detection of anti-drug antibodies (ADAs) and may also apply to some peptides, oligonucleotides, and combination products on a case-by-case basis. The guidance includes recommendations regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. This guidance finalizes the revised draft guidance for industry entitled ‘‘Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products’’ issued in April 2016 and includes a revised title. SUMMARY: VerDate Sep<11>2014 21:23 Jan 31, 2019 Jkt 247001 The announcement of the guidance is published in the Federal Register on February 1, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2009–D–0539 for ‘‘Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 1163 • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document. E:\FR\FM\01FEN1.SGM 01FEN1 1164 Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices Ebla Ali-Ibrahim, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301–796–3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Immunogenicity Testing of Therapeutic Protein Products— Developing and Validating Assays for Anti-Drug Antibody Detection.’’ This guidance finalizes the revised draft guidance for industry entitled ‘‘Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products’’ issued in April 2016. Changes made to the guidance took into consideration comments received. In addition to editorial changes primarily for clarification, this guidance includes updated information on titration and confirmatory assays and an additional discussion of immunogenicity risk assessment. Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety, and efficacy. The clinical effects of patient immune responses are highly variable, ranging from no measurable effect to extremely harmful. Detection and analysis of ADA formation is a helpful tool in understanding potential patient immune responses. Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safety, and efficacy, is crucial for any therapeutic protein product development program. Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled ‘‘Immunogenicity.’’ In general, results from assays for detection of ADA facilitate understanding of the immunogenicity, pharmacokinetics, pharmacodynamics, safety, and efficacy of therapeutic protein products. However, the detection of ADA is dependent on key operating parameters of the assays (for example, sensitivity, specificity), which vary between assays. Therefore, the development of valid, sensitive, specific, and selective assays to measure ADA responses is a key aspect of VerDate Sep<11>2014 21:23 Jan 31, 2019 Jkt 247001 therapeutic protein product development. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.’’ 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 201 have been approved under OMB control number 0910–0572; the collections of information in 21 CFR part 211 have been approved under OMB control number 0910–0139; 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 58 have been approved under OMB control number 0910–0119; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. Dated: January 16, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–00666 Filed 1–31–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–4726] Abbreviated New Drug Application Submissions—Amendments and Requests for Final Approval to Tentatively Approved Abbreviated New Drug Applications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.’’ This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest lawful approval date. DATES: Submit either electronic or written comments on the draft guidance by April 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. E:\FR\FM\01FEN1.SGM 01FEN1
[Pages 1163-1164]
[FR Doc No: 2019-00666]
Immunogenicity Testing of Therapeutic Protein Products--
Developing and Validating Assays for Anti-Drug Antibody Detection;
``Immunogenicity Testing of Therapeutic Protein Products--Developing
and Validating Assays for Anti-Drug Antibody Detection.'' This guidance
provides recommendations to facilitate industry's development and
validation of assays for assessment of the immunogenicity of
therapeutic protein products during clinical trials. The guidance
applies to assays for the detection of anti-drug antibodies (ADAs) and
may also apply to some peptides, oligonucleotides, and combination
products on a case-by-case basis. The guidance includes recommendations
regarding the development and validation of screening assays,
confirmatory assays, titration assays, and neutralization assays. This
guidance finalizes the revised draft guidance for industry entitled
``Assay Development and Validation for Immunogenicity Testing of
Therapeutic Protein Products'' issued in April 2016 and includes a
Register on February 1, 2019.
FDA-2009-D-0539 for ``Immunogenicity Testing of Therapeutic Protein
Products--Developing and Validating Assays for Anti-Drug Antibody
Detection.'' Received comments will be placed in the docket and, except
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
[[Page 1164]]
FOR FURTHER INFORMATION CONTACT: Ebla Ali-Ibrahim, Center for Drug
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research,
7301, Silver Spring, MD 20993-0002, 240-402-7911.
entitled ``Immunogenicity Testing of Therapeutic Protein Products--
Developing and Validating Assays for Anti-Drug Antibody Detection.''
This guidance finalizes the revised draft guidance for industry
entitled ``Assay Development and Validation for Immunogenicity Testing
of Therapeutic Protein Products'' issued in April 2016. Changes made to
the guidance took into consideration comments received. In addition to
editorial changes primarily for clarification, this guidance includes
updated information on titration and confirmatory assays and an
additional discussion of immunogenicity risk assessment.
Immune responses to therapeutic protein products have the potential
to affect product pharmacokinetics, pharmacodynamics, safety, and
efficacy. The clinical effects of patient immune responses are highly
variable, ranging from no measurable effect to extremely harmful.
Detection and analysis of ADA formation is a helpful tool in
understanding potential patient immune responses. Information on immune
responses observed during clinical trials, particularly the incidence
of ADA induction or any implications of ADA responses affecting
pharmacokinetics, pharmacodynamics, safety, and efficacy, is crucial
for any therapeutic protein product development program. Accordingly,
such information, if applicable, should be included in the prescribing
information as a subsection of the ADVERSE REACTIONS section entitled
``Immunogenicity.''
In general, results from assays for detection of ADA facilitate
understanding of the immunogenicity, pharmacokinetics,
pharmacodynamics, safety, and efficacy of therapeutic protein products.
However, the detection of ADA is dependent on key operating parameters
of the assays (for example, sensitivity, specificity), which vary
between assays. Therefore, the development of valid, sensitive,
specific, and selective assays to measure ADA responses is a key aspect
of therapeutic protein product development.
current thinking of FDA on ``Immunogenicity Testing of Therapeutic
Protein Products--Developing and Validating Assays for Anti-Drug
Antibody Detection.'' It does not establish any rights for any person
collections of information in 21 CFR part 201 have been approved under
OMB control number 0910-0572; the collections of information in 21 CFR
part 211 have been approved under OMB control number 0910-0139; 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 58 have been approved under
OMB control number 0910-0119; and the collections of information in 21
CFR part 601 have been approved under OMB control number 0910-0338.
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
[FR Doc. 2019-00666 Filed 1-31-19; 8:45 am]