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Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)
The goal of this program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector.
Emerging manufacturing technology can be viewed as a technology that has the potential to modernize
the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty.
Examples of such elements include an innovative or novel:
(1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.
Emerging manufacturing technology can be viewed as a technology that has the potential to modernize
the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty.
Examples of such elements include an innovative or novel:
(1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.
Agency: Department of Health and Human Services
Office: Food & Drug Administration
Estimated Funding: $6,000,000
Office: Food & Drug Administration
Estimated Funding: $6,000,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of PAR-15-187 on NIH Guide for Grants and Contracts
Additional Information of Eligibility:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U. S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-15-187.html
Contact:
Lisa KoGrants Management Specialist
Agency Email Description:
lisa.ko@fda.hhs.gov
Agency Email:
lisa.ko@fda.hhs.gov
Date Posted:
2015-04-20
Application Due Date:
2019-04-30
Archive Date:
2019-05-30
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