The other day there was a question as to wether or
Post# of 72440
Posted On: 09/15/2016 4:54:42 PM
The other day there was a question as to wether or not the grant funding for Kevetrin's orphan designation could be used fir studies in another country. Well I asked the FDA and the answer is YES. Please see the response below:
P.S. Crooks gonna burn!
On our FAQs : "The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply". "Foreign applications must indicate how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing sciences in the United States."
So, yes that this is allowed since the grants are available to "any foreign entity". You will need a justification in the grant application why US sites will not be involved which will be part of the review.
If you have further questions, please direct them to Katherine.needleman@fda.hhs.gov
P.S. Crooks gonna burn!
On our FAQs : "The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply". "Foreign applications must indicate how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing sciences in the United States."
So, yes that this is allowed since the grants are available to "any foreign entity". You will need a justification in the grant application why US sites will not be involved which will be part of the review.
If you have further questions, please direct them to Katherine.needleman@fda.hhs.gov
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***On 02/26/2016 at 8:33 am Scottsmith admited to posting under 5 aliases but his post was subsequently deleted. I have a screen shot and will email it to anyone interested.
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