FDA Drug Approval Process

This In-house programme will provide your team with a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.

In-house Training and Consultancy Services

A comprehensive overview of FDA procedures, requirements for marketing authorizations and recent developments affecting the drug approval process in the US.

This In-house programme will provide your team with a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

Structure and functions of the Food and Drug Administration. Historical background of US drug approval requirements

General regulatory requirements for drugs

  • Drug definition (drugs versus cosmetics, foods, biologics and medical devices)
  • Labelling rules
  • Patient information requirements
  • Good manufacturing practice regulations
  • Establishment registration and product listing

Regulation of pharmaceutical research. Preclinical research

  • Good laboratory practice
  • Guidelines for toxicity testing and special studies
  • ICH guidelines

Clinical Research

  • The investigational new drug (IND) application
    Content
    1. Procedure for FDA review
    2. Clinical holds
  • Good Clinical Practice
    1. Responsibilities of sponsors and monitors
    2. Responsibilities of investigators
    3. Transfer of responsibilities to contract research organisations (CROs)
  • Informed consent and institutional review boards (IRBs)
  • FDA guidelines for clinical studies
  • ICH guidelines
  • Expanded access programs, including treatment INDs
  • FDA enforcement programmes
    1. Clinical site inspections
    2. Disqualification of investigators
    3. Other

Recommended trainer

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants.