Regulatory Paths to Market - Drugs & Biologics

Biomedical companies must comply with the FDA’s regulatory requirements in order to sell and market medical products in the U.S. Products requiring marketing applications must provide substantial evidence of safety and efficacy, obtained through clinical trials and other studies. It is important to note that marketing applications differ 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 offers expedited regulatory pathways to accelerate the availability of treatments to the public. They have developed several approaches to speed up the approval process for certain medical products to meet existing public health needs, especially treatments for serious diseases. These pathways 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 emergencies such as the COVID-19 pandemic, the FDA can grant an Emergency Use Authorization (EUA).

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