Department of Health and Human Services April 19, 2018 – Federal Register Recent Federal Regulation Documents
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Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug ProductsQuality Considerations.'' The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products, as well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Evaluation of the third decade of the National Occupational Research Agenda (NORA) Council Effectiveness''. This is a survey to collect information from NORA council members and leaders about council activities and satisfaction with council functioning.
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