The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

The Food and Drug Administration plans to extend the compliance deadline for pre-harvest water testing requirements for produce other than sprouts, the agency said in a proposal that also extends the ...

The U.S. Food and Drug Administration (FDA) released its final ruling on requirements for the “healthy” nutrient claim, more than two years after initially proposing an update. Manufacturers must ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic ...

In the changing field of technology, progress is driven by the pursuit of innovation which plays a vital role in enhancing patient care, prolonging lives, and improving overall healthcare outcomes.

The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in ...