Create a free Feed Strategy account to continue reading

FDA says most animal drug companies on board with Guidance #213

The U.S. Food and Drug Administration (FDA) said that, sinceit announced final Guidance for Industry #213 in December 2013, all but oneanimal drug company have committed in writing to seek withdrawal of approvalsfor any production uses of affected drug applications and change the remainingtherapeutic uses of their products from over-the-counter (OTC) to use byVeterinary Feed Directive (VFD) or prescription.On December 11, 2013, the FDA announced theimplementation of its plan to help phase out the use of medicallyimportant antimicrobials in food animals for food production purposes.

The U.S. Food and Drug Administration (FDA) said that, since it announced final Guidance for Industry #213 in December 2013, all but one animal drug company have committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.

On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. FDA asked affected sponsors to notify the agency in writing within three months of their intent to engage with FDA as defined in Guidance #213.

Page 1 of 27
Next Page