[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Draft Guidance for Industry on Metered Dose Inhaler (MDI) and Dry 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availability of a draft guidance for industry entitled ``Metered Dose 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DATES: Written comments may be submitted on the draft guidance document 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ADDRESSES: Copies of this draft guidance are available on the Internet 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single copies of the draft guidance should be submitted to the Drug 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Submit written comments on the draft guidance to the Dockets Management 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draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and 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 This draft guidance sets forth information 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