New Animal Drug Applications

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. 

OEPAflTMENT OF HEALTH AfJO HLTMAIJ SERVICES POOD AND DRUO ADMINISTRATION 

PROPOSE D MARKETIN G STATUS (Chock on f, PRESCRIPTION PRODU CT (Rx) G OVE R T I ENCOUNTER PRODUCT OTC) 

NQTEt No application may i a riled unlasa a completed application form ha l sen reoeivec]. 

Assistant Records Control OfFiccr TSilO Sfandish Place Rockville. MD208SS 

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INSTRUCTIONS FOR PREPARING ANO SUSMITTING THE NEW ANIMAL DRUG APPLICATION... 

Number the pages ol Ihe new animal drug application. Each copy should bear the same page numbering. 

Code of Federal Regulations, 21 Part 514, New Animal Drug Applications, April 1, 2000. 

Abbreviated New Animal Drug Applications (ANADAs), 21 579 Abbreviated New Drug Application (ANDA) process, 21 575 Abbreviations, l xvii—xxiv 2-26 xv-xxii ABCD fiber categorizing system, 9 199 Abciximab, 4 104t 5 173... 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

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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