Accord BioPharma Inc.: INTP1

FDA 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include reinspection of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to your complete response to your application.

Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)].

FDCA, we agree that a REMS will be necessary for INTP23.1, if it is approved, to ensure that the benefits of the drug outweigh the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD) including dialysis-dependent patients associated with INTP23.1.

The REMS, should it be approved, will create enforceable obligations.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the most recent FDA 483 prior to your complete response to your application.

Your complete response should include the date of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.