Tuesday, February 13, 2018

FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs


The U.S Food and Drug Administration today proposed a rule to require animal drug sponsors to submit to the agency certain adverse drug experience and product manufacturing defect reports on Form FDA 1932 in electronic format. Receiving these postmarketing safety reports electronically allows the agency to more rapidly review and identify emerging safety problems and notify veterinarians and animal caretakers about safety signals.

Read entire press release.
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