FDA extending deadline to apply for premarket approval of cellular- and tissue-based products

July 21, 2020

As a result of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) is extending the enforcement discretion policy for certain human cell, tissue, and cellular- and tissue-based products (HCT/Ps), the agency said in a press release.

In November 2017, the FDA developed a regenerative medicine policy framework to help facilitate the development of regenerative medicine therapies. At that time, the agency also outlined its intent to exercise enforcement discretion until November 2020 for certain regenerative medicine products, with respect to the FDA’s IND and premarket approval requirements; to give manufacturers time to determine what requirements apply as well as engage with the agency.

The FDA is revising the guidance, and now says it intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through May 2021.

The agency said the extra time will provide manufacturers and potential sponsors with additional time to determine if they need to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application.

Since the issuance of the comprehensive regenerative medicine policy framework in late 2017, the FDA said it has worked with product developers to determine if they need marketing authorization application and, if so, how they should submit it to the FDA.

The agency said this enforcement discretion policy for IND and premarket approval requirements does not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients. The agency also said it has stepped up its oversight of cellular and related products in recent years and has issued compliance actions, including numerous warning and untitled letters, and pursued litigation for serious violations of the law, including some involving patient harm.

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