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GUIDANCE DOCUMENT

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation Guidance for Industry July 2002

Final
Docket Number:
FDA-1999-D-0060
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document provides guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nasal spray and inhalation solution, suspension, and spray drug products intended for local and/or systemic effect. This guidance covers CMC information recommended for inclusion in the application regarding the drug product components, manufacturing process, and associated controls for each of these areas, but does not address the manufacture of drug substances. The guidance also provides recommendations on labeling. This guidance does not address propellant-based inhalation and nasal aerosols (also known as oral and nasal metereddose inhalers, MDIs), inhalation powders (also known as dry powder inhalers, DPIs), and nasal powders.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0060.