FDA Expands Enforcement Discretion Policy for Certain Regenerative Medicine Products


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The United States Food and Drug Administration extends the Enforcement Discretionary Policy for certain Cell, Tissue, and Human Cell and Tissue (HCT / P) products. Due to the challenges presented by the COVID-19 public health emergency, the FDA is expanding its enforcement discretion policy that will give manufacturers and potential sponsors an additional six months to determine whether they should submit an new investigational medicinal product (IND) or application for marketing and, if such an application is necessary, to prepare and submit the application, if applicable.

The FDA Regenerative Medicine Policy Framework of November 2017 was developed to facilitate and support innovation in regenerative medicine therapies. The agency also underscored its intention to exercise discretion to enforce, until November 2020, for certain regenerative medicine products, with respect to FDA IND and pre-approval requirements. marketing; to give manufacturers time to determine which requirements apply and to engage with the agency. US FDA revises guidance to reflect that FDA generally intends to exercise enforcement discretion with respect to IND and pre-market approval requirements for certain HCT / Ps until May 2021.

“To be clear, our Enforcement Discretion Policy only addresses certain human cells, tissues and cells and tissues products that do not raise significant potential safety concerns or reported safety concerns. This policy was never intended to cover bad actors, and we intend to continue to take action against manufacturers and healthcare providers who offer unapproved regenerative medicine products that may cause a risk to run. significant risk to patients, ”said Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Since the publication of the Comprehensive Regenerative Medicine Policy Framework in late 2017, the FDA has worked with product developers to determine if they need a marketing authorization application and, if so, how they must submit their request to the FDA.

It is important to note that the agency’s discretion policy regarding IND enforcement and pre-market approval requirements does not apply to products that have been associated with problems. safety issues that are reported or may cause significant patient safety concerns. The agency has stepped up its oversight of cellular and related products over the past few years and launched compliance actions, including numerous warning and untitled letters, and prosecuted serious violations of the law, including some involving harm to patients.

Patients should ensure that any regenerative medicine product they are considering is either approved by the FDA or being investigated under an IND, which is a clinical investigation plan submitted and authorized by the FDA.

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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