As another example, in January 2018, FDA granted Fast Track designation to a Zika virus vaccine in development.During a public health emergency, a vaccine may receive Accelerated Approval under 21 CFR §§ 601.40 and 601.41 based on adequate, well-controlled clinical trials establishing an effect on a surrogate endpoint (i.e., biological indicators) that is reasonably likely to predict clinical benefit.In the United States, the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, global nonprofits and private companies are funding vaccine development. On February 25, 2020, the first clinical trial in the United States to evaluate an experimental treatment for COVID-19 began.

In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly referred to as “accelerated approval,” are located in Subpart H (21 C.F.R. § 314.500) of FDA’s drug regulations, and in Subpart E (21 C.F.R. § 601.40) of the Agency’s biologics regulations. If a product meets these criteria, then FDA may grant marketing approval based: (1) on a demonstrated effect on a “surrogate endpoint” and a sponsor’s commitment to complete with “due diligence” the required postmarketing studies to demonstrate the product’s clinical benefits; or (2) on restrictions to assure safe use (that is, when FDA determines that a drug can be used safely only if distribution or use is modified or restricted).

In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly referred to as “accelerated approval,” are located in Subpart H (21 C.F.R. § 314.500) of FDA’s drug regulations, and in Subpart E (21 C.F.R. § 601.40) of the Agency’s biologics regulations. If a product meets these criteria, then FDA may grant marketing approval based: (1) on a demonstrated effect on a “surrogate endpoint” and a sponsor’s commitment to complete with “due diligence” the required postmarketing studies to demonstrate the product’s clinical benefits; or (2) on restrictions to assure safe use (that is, when FDA determines that a drug can be used safely only if distribution or use is modified or restricted, e.g., THALOMID (thalidomide)).