Project Details

National Coordinator for Aquaculture New Animal Drug Applications, Year 02

July 1, 1995

LocationFundingInstitutionPrincipal Investigator(s)
Hawaii $5,000 Michigan State University R. Schnick, T. Batterson
  1. The Coordinator should act as a liaison between the CVM and the aquaculture public. The CVM’s limited resources can, at times, restrict information transfer. In spite of CVM’s authority to disseminate disclosable information, staff limitations can severely curtail this ability, hence, the Coordinator can provide valuable assistance in this regard.
  2. The Coordinator should encourage prospective INAD participants to become involved in specific areas of NADA approval-related research, relative to their capabilities and the needs of the NADA package.
  3. The Coordinator should seek, on behalf of the aquaculture community, the support and/or participation of pharmaceutical sponsors for INAD studies and ultimately NADAs and coordinate with the sponsor to more quickly achieve FDA approval.
  4. The Coordinator should assist prospective and current INAD holders with guidance on the format to follow for INAD exemption requests and related submissions to CVM.
  5. The Coordinator should identify potential participants for specific investigational studies and solicit their participation.