Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological products and drugs, instead moving toward alternative testing models such ...

A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation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

The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...

Well before a human receives the first dose of an experimental drug, it’s evaluated in an animal to test for toxicity. Monkeys are often chosen for their genetic similarities to humans, and safe ...

Organoids, organs-on-a-chip, and machine learning technologies have improved dramatically in recent years, but have they come far enough to replace animal research? Additionally, despite attempts to ...

The US pharmaceutical industry has told the US Food and Drug Administration (FDA) that using process models alone is sufficient for assessing batch uniformity in advanced manufacturing. They believe ...

The bioburden testing market presents opportunities driven by stringent regulations and the need for contamination control in ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

Please provide your email address to receive an email when new articles are posted on . The U.S. has not seen the approval of a new sunscreen ingredient since the 1990s. The FDA’s plan to phase out ...