Most of the hundreds of pages comprising the CARES Act, signed into law on March 27, 2020, concern measures for directly counteracting COVID-19 and assisting those dealing with economic consequences of the pandemic. Yet tucked away in Subtitle F of the legislation are a number of provisions—now law—which streamline FDA’s over-the-counter (OTC) drug review process. These changes are likely to lower the regulatory burden of getting a product through the OTC drug review process and provide incentives of market exclusivity for companies who do.
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