As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate ...

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...

A cannabinoid drug candidate for the treatment of Autism Spectrum Disorder is being explored by in trials, led by Ajna BioSciences, Charlotte's Web, and British-American Tobacco in a joint venture ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing ...

As of October 1, 2024, the Association of American Feed Control Official's (AAFCO) Annual Official Publication is no longer definitive as to which feed additives are FDA-approved or, otherwise, have ...