[Federal Register Volume 64, Number 76 (Wednesday, April 21, 1999)]
[Notices]
[Pages 19543-19544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0674]
Draft Guidance for Industry on IND's for Phase 2 and 3 Studies of
Drugs, Including Specified Therapeutic Biotechnology-Derived Products;
Chemistry, Manufacturing, and Controls Content and Format; 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availability of a draft guidance for industry entitled ``INDs for Phase
2 and 3 Studies of Drugs, Including Specified Therapeutic
Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls
Content and Format.'' This draft guidance is intended to provide
recommendations to sponsors of investigational new drug applications
(IND's) on the chemistry, manufacturing, and controls documentation
(CMC), including microbiology documentation, that should be submitted
for phase 2 and 3 of IND's. This draft guidance applies to human drugs
and specified-biotechnology derived products.
DATES: Written comments on the draft guidance document may be
submitted by July 20, 1999. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance for industry to the Drug Information Branch (HFD-210), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, or the Office of Communication,
Training, and Manufacturers Assistance (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft. Submit written
comments on the draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Charles P. Hoiberg, Center for Drug Evaluation and Research (HFD-
810), Food and Drug
[[Page 19544]]
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2570,
or
Robert A. Yetter, Center for Biologics Evaluation and Research
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for
industry entitled ``INDs for Phase 2 and 3 Studies of Drugs, Including
Specified Therapeutic Biotechnology-Derived Products; Chemistry,
Manufacturing, and Controls Content and Format.'' This draft guidance
is intended to: (1) Facilitate drug discovery and development, (2)
ensure that sufficient data will be submitted for the agency to assess
the safety as well as the quality of the proposed clinical studies from
the CMC and microbiology perspectives, and (3) expedite the entry of
new drugs into the marketplace.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). This draft
guidance represents the agency's current thinking on CMC content and
format of IND's for phase 2 and 3 studies of drugs, including specified
therapeutic biotechnology-derived products. 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 requirements of the applicable statute, regulations, or
both.
II. Comments
Interested persons may submit written comments on the draft
guidance to the Dockets Management Branch (address above). 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 draft guidance and
received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
III. Electronic Access
Copies of this draft guidance are available on the Internet at
``http://www.fda.gov/cder/guidance/index.htm'' or ``http://www.fda.gov/
cber/guidelines.htm''.
Dated: April 13, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-9769 Filed 4-20-99; 8:45 am]
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