- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an increase in unreliable testing data from certain third-party testing labs. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data. Based on data analysis, the FDA determined that Mid-Link Technology Testing Co., Ltd., has in several instances, copied the results of another study or created falsified or otherwise invalid data that was submitted to the FDA. Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected. Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA. The FDA remains committed to taking appropriate actions to address ongoing data integrity concerns.
- Today, the FDA posted six warning letters to companies responsible for introducing unapproved fat dissolving injectable drug products into interstate commerce. The agency reminds consumers that fat-dissolving injections that are not FDA approved can be harmful. The letters were sent to:
- On Friday, the FDA approved Omlyclo (omalizumab-igec) injection, for subcutaneous use to treat certain allergic, inflammatory, and autoimmune conditions. This is the first interchangeable biosimilar to Xolair (omalizumab). Omlyclo works by binding to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors. Omlyclo is administered subcutaneously for all indications but has different dosing instructions for each indication. More information about Omlyclo can be found in the full prescribing information.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
