Adverse events related to unapproved SCRIs continue to be reported in the literature The agency should move quickly to enforce its regulations governing human cell and tissue products for businesses that fail to comply by FDA’s May 31 deadline, and regulators should not hesitate to seek legal injunctions and mandate product recalls when necessary. More broadly, the findings highlight the importance of FDA oversight in ensuring that regenerative products on the market are safe and effective. (See Appendix A for definitions of key terms.) They also underscore how more frequent and thorough reporting of AEs by consumers and clinicians, and the FDA’s use of social media data, could allow the agency to more quickly identify businesses that are putting patients’ health at risk and target its limited oversight resources more effectively. Pew’s findings reinforce the need for increased FDA enforcement action against businesses that manufacture and market these unapproved-and, in many cases, unproven-products.
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