Safety of New Animal Drugs Used in Food-Producing Animals

(06/13/18)

 

FDA Center for Veterinary Medicine Update

Notice of Availability of Guidance for Industry #3

Evaluating the Human Food Safety of New

Animal Drugs Used in Food-Producing Animals

 

FDA Center for Veterinary Medicine has issued a final Guidance for Industry #3, titled 'General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals', which "... describes the type of information that [CVM] recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals.

 

The human food safety evaluation of new animal drugs used in food-producing animals helps ensure that food derived from treated animals is safe for human consumption.

 

CVM developed this guidance to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans ..."

 

The title of the June 11, 2018 FDA e-mail update is "Notice of Availability of Guidance for Industry #3"

 

The title of the July 21, 2016 FDA Federal Register Notice is "General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability"

 

The June 11, 2018 e-mail update was issued by the Food and Drug Administration (FDA)

 

The July 21, 2016 FDA Federal Register Notice was signed on July 14, 2016 by Leslie Kux who is the Associate FDA Commissioner for Policy

 

Comments Due By: Comments on FDA guidance may be submitted at any time

 

Web site: The June 11, 2018 FDA e-mail update is posted at


http://s2027422842.t.en25.com/e/es?s=2027422842&e=98596&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=501a6f7cbb7a4d0c94b95c1f5d390d8a&elqaid=3853&elqat=1

 

The June 2018 FDA CVM Guidance for Industry #3, titled 'General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals',is posted at


http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052180.pdf

 

The July 21, 2016 FDA Federal Register Notice is posted at


http://www.gpo.gov/fdsys/pkg/FR-2016-07-21/html/2016-17188.htm

 

The previous FIEN message related to this topic is posted at


http://www.fien.com/articleDisplay.php?id=37625

 

Questions may be directed to the Policy and Regulations Staff of the FDA Center for Veterinary Medicine in Rockville, Maryland by e-mail at AskCVM@FDA.HHS.gov