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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 an interview with Dr. June Raine, CEO of the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator of medicines, medical devices and blood components for transfusion. The interview was conducted in advance of her meeting in London with a delegation of the FDA’s senior leaders, including the FDA Commissioner Dr. Robert Califf. After the meeting, the FDA Office of Global Policy and Strategy checked in with Dr. Raine again to get her thoughts about that visit.
- Today, the FDA is reminding sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous facilities based in China and India. This alarming trend has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data.
To protect patients and healthcare providers from substandard products and ensure that U.S. patients have access to safe, effective, and high-quality medical devices, the FDA is pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program. At the same time, the FDA is calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.
- On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.
- On Friday, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The most common adverse reactions (≥ 20% incidence) in patients receiving osimertinib plus platinum-based chemotherapy were leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine. View full prescribing information for osimertinib.
- On Friday, Jonathan Nyce, 73, of Collegeville, Pennsylvania, was sentenced to 97 months in prison, three years of supervised release, and a $500 special assessment for carrying out a years-long scheme to defraud pet owners of money by falsely claiming to sell drugs that could cure canine cancer. A federal jury convicted Nyce of wire fraud and the interstate shipment of misbranded animal drugs in December 2022. The case was brought by the Department of Justice, acting on behalf of the FDA.
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