Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
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.