New animal drug application NADA

Depending on whether it is classified as a drug or a biologic, the applicant must submit either a New Animal Drug Application (NADA) to the FDA CVM or veterinary biologies licence applications to the USDA CVB. 

FDA Compliance Program Guidance Manual, Pre-Approval Inspection of New Animal Drug Applications (NADA) (Program 7346.832), February 1991... 

Drug applications typically fall into three categories an NDA, a new animal drug application (NADA), or anabbreviated new drug application (ANDA) for generic products. 

New Animal Drug Application FOI Summaries. URL http // www.fda.gov/cvm/efoi/foidocs.htm. The FDA s Center for Veterinary Medicine also maintains a database of SBA documents associated with original and supplemental NADAs. Known as FOI Summaries because they are released under Freedom of Information Act provisions, these electronic files are accessible through index lists by date (NADA number), generic name, and brand name. 

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