Regulatory Paths to Market - Drugs & Biologics

For a medical product to be available for sale and marketing in the U.S., biomedical companies must meet the regulatory requirements specified by the FDA. Products that need marketing applications must provide substantial evidence that proves the safety and efficacy of the investigational medical product, which is acquired through clinical trials and other studies. Keep in mind that marketing applications are different from the applications needed to conduct clinical trials in human participants. For drugs and biologics, an Investigational New Drug (IND) application is needed before initiating clinical trials.  

The FDA also has expedited regulatory pathways to help get treatments to the public faster. They developed multiple approaches to speed up the approval process of certain medical products to meet existing public health needs, especially treatments for serious diseases. These include Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track. Additional designations for rare diseases include Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT). In cases like the COVID-19 pandemic, the FDA can grant an Emergency Use Authorization (EUA).

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