RE:RE:RE:RE:RE:Interesting past news...ash 1.......Access was not a question in my mind....Note the dates on this letter written in Dec 2018......
December 20, 2018
UPS EXPRESS MAIL
RECIPIENT NAME AND ADDRESS
To Whom It May Concern:
It has come to the attention of the United States Food and Drug Administration (FDA or the Agency), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) that you appear to be offering “stem cell” products to treat a variety of diseases or conditions. FDA generally regulates such products under the Public Health Service Act (PHS Act) as human cells, tissues, or cellular or tissue-based products (HCT/Ps), as defined in 21 CFR 1271.3(d). Although generally regulated as HCT/Ps, such products may also be regulated under the PHS Act and the Federal Food, Drug, and Cosmetic Act (FD&C Act), as biological products, drugs, and/or devices, and may require pre-market review.1
FDA’s November 2017 comprehensive regenerative medicine policy framework is intended to spur innovation and efficient access to safe and effective regenerative medicine products, including HCT/Ps. An overview of the framework is outlined in a suite of four guidance documents that are available on FDA’s website at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm58521 8.htm.
FDA’s final guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, issued in November 2017, informed manufacturers, health care providers, and other interested parties about the Agency’s compliance and enforcement policy for these products. The guidance outlined FDA’s intent to exercise enforcement discretion for the first 36 months following issuance of the guidance for certain products with respect to FDA’s IND and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. This period provides manufacturers time to comply with the IND and premarket approval requirements and engage with FDA to determine whether they need to submit an IND or marketing authorization application, and if so, to submit their application to FDA.
1 For example, in order to lawfully market an HCT/P that is also a biological product and a drug, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products intended for clinical use in humans, generally require an
investigational new drug application (IND).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
Page 2 – RECIPIENT NAME
FDA is currently applying a risk-based approach to enforcement, accounting for how products are being administered and the diseases and conditions for their use, and reminds you that the 36-month period during which FDA intends to exercise enforcement discretion will end in November 2020.2
Manufacturers, health care providers, and other interested parties who have any uncertainty regarding the regulatory status of their products, and who have not already done so, are encouraged to contact FDA well in advance of November 2020, to determine whether their products are subject to the agency’s premarket approval requirements.
For more information on how to contact FDA to obtain a recommendation or decision regarding the classification of an HCT/P, or for further information about IND requirements for biological products, please see pages 23 and 24 of the guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, available at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm58521 8.htm.
Sincerely,
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research
foof