Regulatory Focus

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing methods and increase supply chain visibility. In a proposed rule, the agency said it will enable distributed manufacturers to register as a single entity under a “hub-and-spoke” model and clarified when foreign establishments must register as a manufacturer.

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices without authorization, including devices for eyelid cleaning and an infection control system. Additionally, the agency sent an untitled letter to a company regarding misleading promotional communications for a prescription migraine drug.

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found that the potential leaching of metals from tampon usage in even the most conservative conditions was negligible.

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A Council of Europe committee has warned that “an overly expansive interpretation” of the Medical Device Regulation (MDR) could undermine access to therapies based on human blood, tissues, and cells.

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to issue in 2026, including 22 final and 43 proposed rules by the US Food and Drug Administration (FDA).

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years.

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions about the necessity of inspections and clarifies the agency’s use of alternative methods instead of relying solely on onsite inspections.