Lecture 53 - Epidemiology 5 (FDA) Flashcards
what is the mission of FDA’s center for Veterinary Medicine
to protect human and animal health
the FDA CVM regulates
- animal drugs
- animal food
- animal medical devices
pre-/post- market
T/F: the FDA CVM regulates beef and poultry
FALSE
what composes the Vet-LIRN
- Office of Applied Science
- Office of surveillance and compliance
FDA CVM office of the direct
- oversee and direct general activities
- coordinate and establish policies to support mission
- educate pet owners, animal producers, vets, and animal health industry
FDA CVM office of management
- provide direction for administrative programs
- oversee safety, security, and facility services
FDA CVM office of new animal product evaluation
- manage approval process for new animal products
- ensure new animal products are safe, effective, properly made, and adequately labeled and packaged
- ensure food that food animals are in contact with are safe for people to eat
FDA CVM office of generic animal drugs
- manage approval process for generic animal drugs
- ensure that generic animal drugs are bioequivalent
- ensure drugs used with food animals are safe for people
FDA CVM office of minor use and minor species
- ensure that animal drugs are safe and legally available for minor species and minor uses [in major species]
what are major species
- dogs
- cats
- horses
- cattle
- pigs
- goats
- chickens
FDA CVM office of surveillance and compliance
- monitor products for animals to make sure companies marketing are following the law
- when companies violate the law, take necessary action for compliance
FDA CVM office of applied science
- use science to solve problems and support policies/regulatory decisions
- develop and apply alternative methods to ensure safety and efficacy of drugs
- labs and animal facilities
which one of these is NOT an office at the FDA CVM
a. office of management
b. office of enforcement and recalls
c. office of minor use and minor species
d. office of applied science
b. office of enforcement and recalls
what is the Vet-LIRN
advance the FDA CVM mission of protecting human and animal health by coordinating a network of veterinary diagnostic labs
what does the Vet-LIRN do
- consumer complaint follow-up
- lab proficiency exercises
- AMR monitoring
- method development
- emergency response
who can submit a consumer complaint to FDA about a suspected animal food issue
a. veterinarians
b. animal owners
c. veterinary diagnostic labs
d. all of the above
d. all of the above
Which of the following terms best characterizes the type of surveillance conducted through FDA’s Vet-LIRN (Veterinary Laboratory Investigation and Response Network)? (Choose the single best answer.)
a. Active
b. Syndromic
c. Passive
c. Passive
It often relies on voluntary case submissions from diagnostic laboratories, veterinarians, and pet owners
T/F: Vet-LIRN is regulatory
FALSE - helps decide regulatory action
which of these steps is not routinely conducted by Vet-LIRN?
a. medical record review
b. diagnostic sample testing
c. product recall
d. owner phone interview
c. product recall
if a consumer submits a report to the safety reporting portal regarding pet food, what is Vet-LIRN’s first step?
contact the owner/vet to request medical records
