Biologic licence application

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. 

The dossier submitted to the CDER is known as a new drug application (NDA), which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, then a biologies licence application (BLA) is submitted. 

Senior-level staff need to understand how the communication process works with the FDA, for example, End-of-Phase II Meetings, IND Annual Report, FDA Advisory Committee meetings, Pre-New Drug or Biologic Licence Applications (NDA/BLA) Meetings, clinical holds, IND termination, and FDA audits. 

The term exploratory development (ED) can be defined as the first part of clinical drug development in which tolerabihty, pharmacokinetics and pharmacod)mamic activity are defined in man and in which an early indication of therapeutic efficacy is often obtained. A new molecular entity (NME) can be defined as an unlicensed new chemical or biological entity with activity in biological systems whose therapeutic potential is under investigation. The overall aim of ED should be to select appropriate NMEs for full development (ED), that is, commitment to licence application and to reject those that will not make useful medicines, as early as possible. 

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