CVM Announces First Annual Animal Drug User Fee Educational Conference
July 17, 2024 - On Wednesday, July 17, 2024, CVM will host a public meeting to provide education for stakeholders interested in the new animal drug approval process. Available in-person and virtually, the program will discuss the animal drug approval process and the major technical sections required for ANDA approval. Q&A sessions during which the FDA will address specific questions from the in-person and virtual audience will be done as time allows. MORE INFO

GADA Sponsors Mock BE Large Animal Study for Regulators
September 18-19, 2024 – GADA will sponsor a mock bioequivalence study in large animals as field education exercise for more than 30 FDA CVM regulatory professionals. The mock study will simulate dosing, tissues residue collection and laboratory processing on a swine study on day 1, and a cattle study simulating dosing, BE and blood processing, ending with a feedlot tour on day 2. Participation is limited and available on a first-come, first-serve basis for GADA Member representatives; log in for more details.

Animal Health Regulatory Affairs: Working Successfully with USDA and FDA: An Animal Health Conference sponsored by K-State Olathe
September 17-19, 2024 - K-State Olathe will sponsor an animal health conference focused on how the USDA and FDA each regulate various products and biologics intended for animal use. This three-day program will demonstrate how to navigate the USDA and FDA and provide updates on the EPA. Networking with subject matter experts, a professional skills course and a case study workshop round out the programming. MORE INFO

Animal Drug GMP Inspections Now Under FDA-EU MRA Scope
May 31, 2023
The U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) has been expanded to include inspections of animal drugs. By utilizing each other’s inspection reports and related information, the MRA enables the FDA and the EU to avoid duplication of some animal drug inspections. READ MORE.

GADA in Support of Animal Drug User Fee Reauthorization
March 30, 2023
GADA Chair Stephanie Batliner testified in support of animal drug user fee reauthorization legislation before the Energy and Commerce Committee’s Health Subcommittee on March 30, 2023. Seated behind and to the right is Ben Moses, GADA Vice Chair. The legislation is critical to support efficient and predictable pathways to market for new and innovative animal drugs and generic animal drugs. GADA represents the generic animal drug industry in negotiations with the FDA Center for Veterinary Medicine.

July 17, 2024
CVM Public Meeting: First Annual Animal Drug User Fee Educational Conference
FDA Headquarters, Silver Spring, MD/Virtual

September 17-19, 2024
Animal Health Conference: Animal Health Regulatory Affairs: Working Successfully with USDA and FDA
K-State Olathe Campus, Olathe, KS

September 18-19, 2024
GADA-Sponsored Mock BE Large Animal Study
Oakland, NE
MEMBERS ONLY - Log in for details/registration

Wednesday, October 16, 2024
GADA Annual Member Meeting
Rockville, MD
MEMBERS ONLY - Log in for details/registration

Thursday, October 17, 2024
GADA-CVM Triannual
Rockville, MD/Virtual
MEMBERS ONLY - Log in for details/registration