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Surveillance Update GADA/CVM Meeting

Surveillance Update GADA/CVM Meeting. Neal Bataller, ME, DVM Division of Surveillance FDA/Center for Veterinary Medicine. Organizational Changes. Division of Surveillance ~ Has Now Become ~ Division of Surveillance Division of Veterinary Product Safety.

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Surveillance Update GADA/CVM Meeting

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  1. Surveillance Update GADA/CVM Meeting Neal Bataller, ME, DVM Division of Surveillance FDA/Center for Veterinary Medicine

  2. Organizational Changes • Division of Surveillance ~ Has Now Become ~ • Division of Surveillance • Division of Veterinary Product Safety

  3. Division of Veterinary Product Safety • Adverse Drug Event Review Team (HFV-241) • Dr. Linda Walter-Grimm • Adverse Event Review Team (HFV-242) • Dr. Lee Anne Palmer • Data Management and Analysis Team (HFV-243) • Dr. Susan Bright

  4. Division of Surveillance • Marketed Product Information Team (HFV-212) • Ms. Sue Dessai • Unapproved Drug, Jurisdictional, and Hazard Review Team (HFV-214) • Dr. Vitolis Vengris • Post-Approval Review Team (HFV-216) • Dr. Dottie McAdams

  5. Issues of Interest • Section 105 reporting (Form FDA 3744) • Generic labels • Distributor labels • Tradenames • Promotion and advertising • Delinquent reporting • Unapproved drugs and compounding

  6. Possible Paths Forward • Enforcement • Import controls • Regulatory changes • Additional guidance • Form revisions • Electronic submission • Outreach

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