CARES Act Submission Assistance

CARES Act Submission Assistance

In order to comply with CARES Act Section 510(j)(3), pharmaceutical businesses are required to use the CDER NextGen portal to submit to the USFDA the manufacturing and distribution details of their medicines. This reporting comprises comprehensive CSV submissions that cover a range of drug categories, including active pharmaceutical ingredients (API) and formulations (both prescription and over-the-counter).

In CARES Act a 10-digit National Drug Code (NDC) number for each product, the Data Universal Numbering System (DUNS) number, the month-by-month quantity sent to the USA, and the overall quantity for each reporting period are among the fields that must be included in the needed CSV file. The NextGen CDER portal is used to validate these submissions, guaranteeing their accuracy and adherence to legal specifications.

One of the main aspects of the CARES Act in terms of FDA regulation is the streamlining of drug-related processes and better tracking of drug products, especially to ensure they’re accessible in emergency situations.

The Act included provisions to encourage the development of generic and biosimilar drugs, which can be crucial during emergencies. By making it easier for these alternatives to enter the market, the government aimed to enhance the accessibility and affordability of drugs, particularly during emergencies when access to brand-name drugs may be limited.

The CARES Act also sought to increase the FDA’s ability to gather real-time data from manufacturers, distributors, and other stakeholders to better monitor the availability of critical drugs. This was done to help predict shortages and address them proactively.

As required by section 510(j)(3) of the FD&C Act, Masuu US Agent assists pharmaceutical businesses in completing CARES reporting to the USFDA. The amounts of each mentioned medication that have been produced, prepared, distributed, compounded, or processed for commercial use must be reported.

The services offered by Masuu US Agent include ensuring timely and accurate submissions to support compliance with the CARES Act requirements, validating the data to satisfy USFDA standards, and preparing the required data in the appropriate CSV format.