FDA 21 CFR 10.75 SUPPLEMENT
This document will supplement your existing 21 CFR 10.75 Administrative Appeal with FDA to include the recent decision by the US 11th Circuit Appeals Court decision that FDA must review all information, including marketing plans, in an application prior to issuing a denial order. This document will supplement your appeal to request that in light of the 11th circuits ruling, FDA set aside the MDO, grant the appeal, and proceed with a full scientific review of the application.
If your PMTA is subject to any ongoing litigation, do not submit an appeal or supplement without advice from your legal counsel.
Once you purchase the 10.75 supplement, a representative will reach out to you VIA THE EMAIL ADDRESS YOU USE TO COMPLETE CHECKOUT to request company specific information that is needed to process the document.
Once your appeal request in complete, it will be returned to you via email with instructions for uploading the document to your CTP portal and submitting it to CTP via email correspondence.
Note: If you have not previously submitted a 10.75 appeal request to FDA, you will need to purchase and complete that document prior to submitting the supplement.
This document will supplement your existing 21 CFR 10.75 Administrative Appeal with FDA to include the recent decision by the US 11th Circuit Appeals Court decision that FDA must review all information, including marketing plans, in an application prior to issuing a denial order. This document will supplement your appeal to request that in light of the 11th circuits ruling, FDA set aside the MDO, grant the appeal, and proceed with a full scientific review of the application.
If your PMTA is subject to any ongoing litigation, do not submit an appeal or supplement without advice from your legal counsel.
Once you purchase the 10.75 supplement, a representative will reach out to you VIA THE EMAIL ADDRESS YOU USE TO COMPLETE CHECKOUT to request company specific information that is needed to process the document.
Once your appeal request in complete, it will be returned to you via email with instructions for uploading the document to your CTP portal and submitting it to CTP via email correspondence.
Note: If you have not previously submitted a 10.75 appeal request to FDA, you will need to purchase and complete that document prior to submitting the supplement.
This document will supplement your existing 21 CFR 10.75 Administrative Appeal with FDA to include the recent decision by the US 11th Circuit Appeals Court decision that FDA must review all information, including marketing plans, in an application prior to issuing a denial order. This document will supplement your appeal to request that in light of the 11th circuits ruling, FDA set aside the MDO, grant the appeal, and proceed with a full scientific review of the application.
If your PMTA is subject to any ongoing litigation, do not submit an appeal or supplement without advice from your legal counsel.
Once you purchase the 10.75 supplement, a representative will reach out to you VIA THE EMAIL ADDRESS YOU USE TO COMPLETE CHECKOUT to request company specific information that is needed to process the document.
Once your appeal request in complete, it will be returned to you via email with instructions for uploading the document to your CTP portal and submitting it to CTP via email correspondence.
Note: If you have not previously submitted a 10.75 appeal request to FDA, you will need to purchase and complete that document prior to submitting the supplement.