Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...

Indeed, in new draft guidance on the use of AI to support regulatory decision-making for drug and biological products, FDA described using ... part of the diagnostic process and is therefore ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...

Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...

For example, the US Food and Drug Administration (FDA) and the European Medicines ... a critical factor in the accomplishment of the regulatory process. This implies that potential regulatory ...

DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs Market ... which is expected to speed up the approval process of the FDA for certain types of drugs. The FDA has launched four ...

Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...