A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation surgeries. The objective ...

Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies (mAbs), the latest expansion of the regulator’s efforts to eliminate animal ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.