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Types of FDA Regulatory Submissions

As pharmaceutical professionals, we know that the US FDA regulatory process can be complex and challenging. That's why it's important to understand the different types of filings for drugs and other pharmaceutical products. Here are some filing details that you should be aware of:

505(a) NDA: This is for a new drug product that hasn't been previously approved by the FDA.

505(j) ANDA: This is for a generic drug product that's intended to be bioequivalent to a previously approved brand-name drug product.

505(b)(1) NDA: This is for a drug manufacturer that has conducted its own studies and hasn't relied on data from a previously approved drug product.

505(b)(2) NDA: This is for a drug manufacturer that can rely, in part, on data that has already been established for an approved drug product.

Supplemental NDA (sNDA): This is for requesting changes or additions to an already approved drug product.

Emergency Use Authorization (EUA): This is for responding to public health emergencies, such as the COVID-19 pandemic.

Each type of filing has its own unique requirements and timeline for review by the FDA. The FDA carefully evaluates all filings to ensure the safety and efficacy of pharmaceutical products marketed in the United States. As pharmaceutical professionals, it's important for us to stay informed about these regulatory processes.

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