Animal Drugs at FDA Phase 3 Implementation

(AGENPARL) - Silver Spring,  -

December 7, 2017

In our continued effort to improve transparency and public access to information about approved animal drugs, the U.S. Food and Drug Administration’s Center for Veterinary Medicine is launching Phase III of the redesigned Animal Drugs @ FDA website.

As before, the new Animal Drugs @ FDA website provides a searchable database for veterinarians, pet owners, animal producers and others to get information about approved animal drugs by application number, sponsor name, proprietary name, ingredient, application status, dosage form, route of administration, indication and species.

With the completion of Phase 3 on December 6, 2017, Animal Drugs @ FDA will now display animal drug information using the FDA Structured Product Labeling (SPL) style sheet. This enhancement will permit CVM to post, approved animal drug SPL files in the future. Once posted, approved animal drug SPL files will provide additional information that includes all content of labeling and images of labeling components. Additional enhancements that were completed in this phase include:

  • Adding of the marketing status to the search results table to better distinguish between approved and voluntarily withdrawn applications
  • Updating the Advance Search Logic to always use “and” searches instead of “or” searches when entering multiple search criteria

Additional enhancements made on November 9, 2017, include:

  • Creation of an FOI Summary display page listed by Application number
  • Creation of an Environmental Documents page with all Environmental Assessment and Findings of No Significant Impact documents listed by chemical entities
  • Creation of a Non-Steroidal Anti-Inflammatory Drugs (NSAID) labeling page which displays package insert and client information sheets for some NSAID products

For more information about the redesigned Animal Drugs @ FDA, contact CVMGreenBookandAnimalDrug@fda.hhs.gov.
 

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