A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Many physicians are unfamiliar with how the Food and Drug Administration’s (FDA) regulates new drugs and medical devices, and they may be under the impression that the data supporting these approvals ...

NEW YORK (Thomson Reuters Regulatory Intelligence) - No matter what the policies are, and no matter who in your organisation writes them, they have to get approved. That approval process is vital to ...