Understanding the Us Fda regulations

The Food and Drug Administration (FDA) in the USA remains the dominant regulatory authority in the world. An understanding of the FDA regulatory structure, operations and functions is very important to individuals new to the pharmaceutical industry or new to the industry within the USA. The different approaches of the Drug and Biologies Divisions should be understood. Staff need to identify and understand FDA investigational drug IND and biologic regulations and FDA guidelines and regulations.

Knowledge and skills are required for the specific regulations governing drug development in the USA. These include Title 21, Code of Federal Regulations Parts 50,56,312 and 314.

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.

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