[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9196-9197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5006]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0259]
``Points to Consider in the Manufacture and Testing of Monoclonal
Antibody Products for Human Use (1997);'' 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 points to consider (PTC) document entitled ``Points
to Consider in the Manufacture and Testing of Monoclonal Antibody
Products for Human Use (1997).'' This PTC document is intended to
assist sponsors and investigators engaged in monoclonal antibody
product development and it includes information to submit when filing
investigational new drug applications and product license applications.
The document revises a 1994 document entitled ``Draft Points to
Consider in the Manufacture and Testing of Monoclonal Antibody Products
for Human Use.''
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the document
entitled ``Points to Consider in the Manufacture and Testing of
Monoclonal Antibody Products for Human Use (1997)'' to the
Manufacturers Assistance and Communication Staff (HFM-42), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. The
document may also be obtained by mail or fax by calling the CBER Fax
Information System at 1-888-CBER-FAX or 301-827-3844.
Persons with access to the Internet may obtain the document using
the World Wide Web (WWW) or bounce-back e-mail. For WWW access, connect
to CBER at ``http://www.fda.gov/cber/cberftp.html.'' For bounce back e-
mail send a message to ``[email protected].''
Submit written comments on the PTC document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. A copy of the PTC document
and received comments are available for public examination in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a PTC
document entitled ``Points to Consider in the Manufacture and Testing
of Monoclonal Antibody Products for Human Use (1997).'' This PTC
document supersedes the document entitled ``Draft Points to Consider in
the Manufacture and Testing of Monoclonal Antibody Products for Human
Use'' announced in the Federal Register of August 3, 1994 (59 FR
39571), and is designed to assist sponsors and investigators engaged in
monoclonal antibody product development.
The PTC revision was undertaken for reasons that include but are
not limited to: (1) Facilitating initial development of monoclonal
antibodies for serious and immediately life-threatening indications;
(2) updating and streamlining information from the 1994 PTC document;
and (3) assuring consistency with current CBER policy and International
Conference on Harmonisation documents dealing with this category of
products. In the revision of this document, CBER reviewed and
considered all comments submitted to the docket.
The PTC document details an approach for sponsors and investigators
to follow in product manufacturing and testing, preclinical and
clinical studies, and the information to be provided for
[[Page 9197]]
review and evaluation of clinical testing and licensing. This document
applies to monoclonal antibodies made by traditional hybridoma
technology as well as by recombinant technologies. Some of the major
changes in the revised PTC document include: (1) An updated definition
of a monoclonal antibody; (2) modification of the quality control,
product testing, and product comparability sections; and (3)
clarification of the techniques for and necessity of retrovirus
testing. The section of the draft 1994 PTC document dealing with
changes to be reported after product approval is not included in the
1997 PTC document because this subject is addressed in a separate
rulemaking (61 FR 2739, January 29, 1996).
A new section of the document discusses abbreviated product testing
for feasibility trials in serious and immediately life-threatening
conditions. Other important new concepts contained in the revised PTC
document are those of generic and modular virus clearance studies and
the acceptability of demonstrating the removal of some contaminants by
means of clearance studies, as opposed to routine testing. The concepts
of generic and modular virus clearance studies and of clearance studies
for some contaminants apply not only to monoclonal antibodies but also
to recombinant products, as appropriate. CBER intends to update other
guidance documents to reflect these studies. New concepts on
abbreviated product testing for feasibility trials in serious and
immediately life-threatening conditions and on generic and modular
virus clearance studies do not apply to products of entirely human
origin or to products that have the potential to be contaminated by
human pathogens.
As with other guidance documents, FDA does not intend the PTC
document to be all inclusive and cautions that not all information may
be applicable to all situations. The document is intended to provide
information and does not set forth requirements. Manufacturers may
follow the document or may choose to use alternative procedures that
are not provided in this document. If a manufacturer chooses to use
alternative procedures, that manufacturer may wish to discuss the
matter further with FDA to prevent expenditure of resources to generate
data on activities that FDA may later determine to be unacceptable.
Although this document does not create or confer any rights for or on
any person and does not operate to bind FDA or the public, it does
represent the agency's current thinking on the manufacture and testing
of monoclonal antibody products for human use.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the PTC document.
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. Received
comments may be seen in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
Received comments will be considered in determining whether further
revision of the PTC document in warranted. Any revised version of the
PTC document will be announced in the Federal Register.
Dated: February 20, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5006 Filed 2-27-97; 8:45 am]
BILLING CODE 4160-01-F