FDA and Quality Services RFP : 836 Summary Close A.L. Philpott Manufacturing Extension Partnership Joshua Dawson Non-Professional Services - Non-Technology Request for Proposals (RFP) Published On : 10/30/20 Amended On : Closing On : 11/20/20 5:00 PM Intent Posted On: Open Time Left : 18 Days
These services will occur from 2022 to 2024 with general specifications for regulatory and quality services guidance for the submission of a 510(k) application to FDA, which will allow marketing of the VA-designed implant in the United States. This will include review of testing protocols, submission of an Investigational Device Exemption (IDE) as well as a submission of a 510(k) application.
The Department of Veterans Affairs, San Francisco VA Medical Center (SFVA), needs services for regulatory and quality guidance for the submission of a 510(k) application to FDA, which will allow marketing of the VA-designed implant in the United States. This will include review of testing protocols, submission of an Investigational Device Exemption (IDE) as well as a submission of a 510(k) application.
The antibiotic(s) must be FDA-approved or in Phase 3 clinical development and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic is not FDA approved for a pneumonic indication, the Offeror must seek development and FDA approval for a pneumonic indication that could support approval of a biothreat indication.
The antibiotic(s) must be FDA-approved or in Phase 3 clinical development and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic is not FDA approved for a pneumonic indication, the Offeror must seek development and FDA approval for a pneumonic indication that could support approval of a biothreat indication.
At a minimum, the drug should have established efficacy parameters as determined by the FDA in at least two appropriate orthopoxvirus animal model (e.g.
At a minimum, the drug should have established efficacy parameters as determined by the FDA in at least two appropriate orthopoxvirus animal model (e.g.
