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In September, FDA proposed a rule that would end the enforcement discretion policy for LDTs by treating them as IVDs subject to regulatory requirements as medical devices. We just published a deep dive into the Proposed Rule and what it could mean for impacted firms on our Insider Newsletter. Here’s a quick rundown: 🔹 LDTs have been exempt from pre-market review and regulatory requirements due to their limited use.

Title: Navigating the FDA’s New Cybersecurity Rules for Medical Devices Introduction:As of October 1, 2023, the grace period for enforcing new cybersecurity regulations on medical devices by the FDA has come to an end. These regulations, outlined in Section 524B of the FD&C Act, were introduced as part of the Consolidated Appropriations Act of 2023.

Title: Researchers Uncover Omission of Deaths in Pfizer’s COVID Vaccine Clinical Trial Data Summary:A recently published study by the Daily Clout Pfizer/BioNTech Documents Investigations Team suggests that Pfizer excluded known deaths in the vaccine arm of its COVID-19 clinical trial when submitting data for Emergency Use Authorization (EUA) to the FDA. The study reveals that delayed reporting of these deaths obscured a significant adverse event signal, allowing Pfizer’s EUA request to proceed unchallenged.

Title: FDA and MITRE Collaborate to Address Legacy Medical Device Cybersecurity Risks Date: November 15, 2023 Summary: In response to the increasing cybersecurity threats posed by legacy medical devices, the FDA has partnered with MITRE to develop a comprehensive report titled “Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks.” Legacy devices, which were legally introduced to the market, may lack adequate cybersecurity controls against current threats, posing risks to the healthcare sector.

The U.K. recently approved the drug anastrozole for post-menopausal women at risk of developing breast cancer. This decision drew attention from U.S. breast medical oncologists who have long prescribed anastrozole, along with other drugs like tamoxifen and raloxifene, for those at moderate to high risk of breast cancer. Anastrozole, which reduces estrogen production, received U.K. approval for preventive use, while in the U.S., tamoxifen and raloxifene are FDA-approved for this purpose.

Summary:A European regulator has confirmed that BioNTech, a partner of Pfizer, did not specifically highlight a DNA sequence in its COVID-19 vaccine, Comirnaty. The European Medicines Agency (EMA) stated that although the full DNA sequence was provided in the initial marketing authorization application, BioNTech did not highlight the Simian Virus 40 (SV40) sequence. The SV40 sequence has raised concerns, with some experts suggesting it could act as a mutagen.

Title: The Changing Landscape of Medical Device Safety: Three Trends Shaping the Future In the realm of medical device manufacturing, the prevalent belief has been that as long as products are deemed safe and effective, and there are no regulatory issues, patient safety is assured. However, three recent trends are reshaping this landscape, emphasizing the need for a strategic focus on patient safety throughout the product lifecycle.

Subscribe to Email Updates  Share  Post Linkedin Email Print On October 3, 2023, the FDA published a proposed rule entitled “Medical Devices; Laboratory Developed Tests.”  Following publication of the proposed rule, the FDA has received requests for an extension of the comment period.

Title: Former Military Members Sue US Government for Billions in Lost Wages Over COVID-19 Vaccine Discharge Summary: A group of former military members has filed three federal lawsuits seeking compensation, including backpay and benefits restoration, after being discharged for refusing the COVID-19 vaccine. The lawsuits argue that Congress’s directive to rescind the vaccine mandate implies retroactive application. The suits highlight Defense Secretary Lloyd Austin’s commitment to correcting adverse actions resulting from non-compliance.

Texas attorney general accuses Pfizer of fraud.Pfizer ‘Knowingly Distributed’ Adulterated Drugs to Children: LawsuitThe Pfizer Pharmaceutical company logo is displayed at Discovery Park in Sandwich, England, on Aug. 17, 2011. ( Dan Kitwood/WPA Pool/Getty Images)Zachary StieberBy Zachary Stieber11/21/2023Updated:11/21/2023 Pfizer and one of its partners distributed a medication to children while knowing that the drug was adulterated, according to legal action unsealed on Nov. 20.