Amulti site trial of bioabsorbable steroid-eluting sinus implants

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Organizations must submit applications to (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH's electronic system for grants administration. NIH and systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Therefore, a study record that (1) does not list "United States" (or a . territory) for the Facility Information/Country data element, (2) lists "No" for the . Food and Drug Administration IND or IDE data element, and (3) lists "No" for the Product Manufactured in and Exported from the . data element, would indicate that a studied drug or biologic product is not "subject to" section 505 of the FD&C Act or section 351 of the PHS Act. For such a study, the responsible party would answer "No" to the Studies a . FDA-regulated Drug Product data element and the study would not be considered an applicable drug clinical trial. Note that even if the drug or biologic product being studied had previously been approved by the . FDA under section 505 of the FD&C Act or section 351 of the PHS Act for marketing in the ., that responsible party would list "No" for the Studies a . FDA-regulated Drug Product data element because the particular drug or biological product used in that study is not subject to those sections of the FD&C Act or PHS Act.

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Amulti site trial of bioabsorbable steroid-eluting sinus implants

a multi site trial of bioabsorbable steroid-eluting sinus implants

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Multi Data Rescue™

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DVD Data Rescue®

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