Regulatory Brief

 Proposed collection of drug adverse event information by the FDA


Formal title: Docket Number [2006N-0180] Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs

On May 19, 2006 the FDA published a notice soliciting comments on the burden and utility of collecting drug adverse event information.

AVMA Response:

The AVMA is committed to the continuing availability of medicinal products that are pure, safe, potent and efficacious for animals. The AVMA encourages continued development and strengthening of adverse event reporting systems. This includes continued collaboration with constituent professional organizations, industry organizations, government entities and other stakeholders.

Background Documents:

View AVMA's first response to FDA (PDF)

View Federal Register document (PDF)

Status:

AVMA responded on May 31, 2006.