Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01)

The summary for the Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01): The project highlights the following important areas in chemistry, manufacturing and controls of dry powder inhaler (DPI) drug products: -Controlling the manufacturing of API crystals in order to obtain micronized API materials with low variability and consistency; -Defining the critical quality attributes of the API crystals that must be measured and controlled to ensure quality in the final drug product; -Emphasizing the relationship between the properties of the API crystals and the quality of micronized API materials to be in included in the final drug product; -Exploring the effects of post-micronization relaxation of micronized API on product performance, with an aim to understand the requirements for laagering and quarantining of micronized API materials.
Federal Grant Title: Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01)
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Agriculture Business and Commerce Consumer Protection Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-11-029
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: August 15th, 2011
Original Application Deadline: August 15th, 2011
Posted Date: July 18th, 2011
Creation Date: July 18th, 2011
Archive Date: September 14th, 2011
Total Program Funding: $160,000
Maximum Federal Grant Award: $160,000
Minimum Federal Grant Award: $1
Expected Number of Awards: 1
Cost Sharing or Matching: No
Last Updated: July 18th, 2011
Applicants Eligible for this Grant
County governments - City or township governments - Independent school districts - Native American tribal governments (Federally recognized) - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - For-profit organizations other than small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.
Link to Full Grant Announcement
NIH Guide Announcement Link
Grant Announcement Contact
Lisa Ko
Grants Management Specialist
[email protected]
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