FDA explains transfer of ownership policy for generics

The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.

The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.