[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64270-64271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0997]
Draft Guidance for Industry on Metered Dose Inhaler (MDI) and Dry
Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and
Controls Documentation; 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availability of a draft guidance for industry entitled ``Metered Dose
Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry,
Manufacturing, and Controls Documentation.'' This draft document
provides guidance for industry on the chemistry, manufacturing, and
controls (CMC) documentation to be submitted in new drug applications
(NDA's) and abbreviated new drug applications (ANDA's) for metered dose
inhalation aerosols, metered dose nasal aerosols, and inhalation
powders.
DATES: Written comments may be submitted on the draft guidance document
by February 17, 1999. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of this draft guidance are available on the Internet
at ``http://www.fda.gov/cder/guidance/index.htm.'' Written requests for
single copies of the draft guidance should be submitted to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Submit written comments on the draft guidance to the Dockets Management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: Guirag Poochikian, Center for Drug
Evaluation and Research (HFD-570), Food and Drug Administration, 5600
Fishers Lane, rm. 10B45, Rockville, MD 20857, 301-827-1050.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and
Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and
Controls Documentation.'' This draft guidance sets forth information
that should be provided to ensure continuing drug product quality and
performance characteristics for MDI's and DPI's. In addition to
providing guidance on CMC documentation to be submitted in NDA's and
ANDA's for DPI's and MDI's, the draft guidance covers CMC information
recommended for inclusion in the application with regard to the
components, manufacturing process, and the controls associated with
each of these areas. The document does not address inhalation solutions
or aqueous nasal sprays.
FDA intends to sponsor a public meeting in 1999 on MDI and DPI drug
products. The comments submitted on
[[Page 64271]]
this draft guidance will be used to help develop the agenda for this
meeting.
This draft level 1 guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on CMC documentation
to be submitted in NDA's and ANDA's for metered dose inhalation
aerosols, metered dose nasal aerosols, and inhalation powders. 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 statute,
regulations, or both.
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.
Dated: November 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30938 Filed 11-18-98; 8:45 am]
BILLING CODE 4160-01-F
