CARES Act Submission Assistance

CARES Act Submission Assistance

CARES Act Submission Assistance : Pharmaceutical companies must report the manufacturing and distribution details of their products to the USFDA using the CDER NextGen portal, particularly for compliance with the CARES Act Section 510(j)(3). This reporting includes detailed CSV submissions covering various types of drugs, such as formulations (both Rx and OTC) and active pharmaceutical ingredients (API).

The required CSV file must include fields such as the Data Universal Numbering System (DUNS) number, a 10-digit National Drug Code (NDC) number for each product, and the month-wise quantity sent to the USA, along with the total quantity for each reporting period. The validation of these submissions is performed within the NextGen CDER portal, ensuring accuracy and compliance with regulatory requirements.

Masuu US Agent supports pharmaceutical companies in submitting CARES reporting to the USFDA, as mandated under section 510(j)(3) of the FD&C Act. This involves reporting the quantities of each listed drug that have been manufactured, prepared, propagated, compounded, or processed for commercial distribution.

Masuu US Agent’s services include preparing the necessary data in the correct CSV format, validating the data to meet USFDA standards, and ensuring timely and accurate submissions to facilitate compliance with the CARES Act requirements.