[Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
[Notices]
[Pages 1939-1940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-943]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0386]
Guidance for Industry; Content and Format of Investigational New
Drug Applications (IND's) for Phase 1 Studies of Drugs, Including Well-
Characterized, Therapeutic, Biotechnology-Derived Products;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry; Content
and Format of Investigational New Drug Applications (IND's) for Phase 1
Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-derived Products.'' The guidance clarifies data
requirement issues related to the initial entry of an unapproved drug
into human studies in the United States. The guidance is intended to
expedite the entry of new drugs into clinical studies by eliminating
ambiguities in IND requirements and by decreasing inconsistencies in
IND reviews.
DATES: Written comments on the guidance may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry; Content and Format of Investigational
New Drug Applications (IND's) for Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-derived Products'' to
the Consumer Affairs Branch (formerly the CDER Executive Secretariat
Staff), Center for Drug Evaluation and Research (HFD-210), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, or the
Congressional and Consumer Affairs Branch, Center for Biologics
Evaluation and Research (HFM-12), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-594-1800 or
800-835-4709. Send two self-addressed adhesive labels to assist the
offices in processing your requests. A copy of the guidance document is
also available from CDER's FAX On Demand. To obtain a copy from FAX On
Demand, call 1-800-342-2722 or locally 301-827-0577. An electronic
version of the guidance document is also available via Internet.
Requesting persons should connect to the CDER file transfer protocol
(FTP) server (CDVS2.CDER.FDA.GOV) using the FTP protocol. The guidance
is available in WordPerfect versions 5.2 and 6.0. Submit written
comments on the guidance to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. Requests and comments should be identified with the docket
number found in brackets in the heading of this document. A copy of 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.
FOR FURTHER INFORMATION CONTACT: Murray M. Lumpkin, Center for Drug
Evaluation and Research (HFD-2), Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20852, 301-594-6740, or Rebecca Devine,
Center for Biologics Evaluation and Research (HFM-10), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance entitled ``Guidance for Industry; Content and Format of
Investigational New Drug Applications (IND's) for Phase 1 Studies of
Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived
Products.'' Any use in humans in the United States of a drug product
not
[[Page 1940]]
previously authorized for marketing in the United States first requires
the submission of an IND to FDA. FDA regulations in Secs. 312.22 and
312.23 (21 CFR 312.22 and 312.23) contain the general principles
underlying the IND submission and the general requirements for an IND's
content and format. This guidance clarifies these requirements related
to the initial entry of an unapproved drug, including well-
characterized, therapeutic, biotechnology-derived products. -
Because of the manufacturing and toxicologic differences between
well-characterized, therapeutic, biotechnology-derived products and
other biologic products, the guidance only applies to drugs that are
not also biologics and to well-characterized, therapeutic,
biotechnology-derived biologic products. For products not covered by
the guidance the center responsible for the product should be contacted
for guidance.
The requirements in Secs. 312.22 and 312.23 permit a great deal of
flexibility in the amount and depth of data to be submitted in an IND,
depending in large part on the phase of the investigation and the
specific human testing proposed. In some cases, the extent of that
flexibility and the limited data needed has not been appreciated. FDA
believes that clarification of these requirements will decrease the
submission of unnecessary data and help expedite the entry of new drugs
into clinical testing by increasing transparency and reducing ambiguity
and inconsistencies. These clarifications will reduce the amount of
information ordinarily submitted in an IND, yet continue to provide the
agency with the data it needs to assess the safety of the proposed
Phase 1 study.
The most significant clarifications contained in the guidance are
FDA's willingness to accept an integrated summary report of toxicology
findings as initial support for human studies based upon unaudited,
draft, toxicological reports of completed animal studies, as well as
specific manufacturing data that FDA will accept as appropriate for a
Phase 1 study. This guidance applies equally to both commercial and
individual investigator sponsors of IND's.
As part of the President's Reinventing Government Initiative, FDA
has been reviewing its regulatory processes to determine which
requirements could be reduced or eliminated without lowering health and
safety standards. These clarifications of the IND requirements have
been identified during this review and should significantly reduce the
burden on industry regarding data submitted in Phase 1 IND's without
sacrificing the quality of FDA's review of the IND.
In addition to this guidance, FDA is preparing an advance notice of
proposed rulemaking (ANPR) that will describe proposed revisions to the
IND regulations that FDA is contemplating to facilitate further the
entry of drugs into clinical studies so that safe and effective drugs
can be made available in the United States more quickly. The ANPR is
expected to be published in the first quarter of 1996 and will address
the possibility of: (1) A specific single dose IND with limited data
requirements and (2) reducing or eliminating the IND submission
requirements for individual investigators who would like to use
products already in Phase 2 of commercial development.
Although this guidance does not create or confer any rights for or
on any person and does not operate to bind FDA or the industry, it does
represent the agency's current thinking on data requirement issues
related to the initial entry of an unapproved drug into human studies
in the United States.
Although the guidance is being implemented immediately because it
merely clarifies existing regulations and is expected to reduce the
data submission burden on the industry, FDA is soliciting comments on
the guidance that will be taken into account in making further
revisions or clarifications to the IND process. FDA is particularly
interested in comments on how the guidance could be extended to cover
biological products other than well-characterized, therapeutic,
biotechnology-derived products or whether a separate guidance should be
developed for those products.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. 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 may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. -
Dated: January 8, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-943 Filed 1-23-96; 8:45 am]
BILLING CODE 4160-01-F
