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

credit:


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.

Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food & Drug Administration

Estimated Funding: $6,000,000


Who's Eligible


Relevant Nonprofit Program Categories





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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