OpportunityTitle: Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)
AdditionalInformationOnEligibility: 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.
Description: 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.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist &lt;br/&gt;
CloseDateExplanation: This announcement has multiple deadline dates.June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time.April 28, 2017, by 8:00 PM Eastern Time.April 30, 2018, by 8:00 PM Eastern Time.April 30, 2019, by 8:00 PM Eastern Time.Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process.For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.  For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date.  Late applications will not be accepted for this FOA.