FDA laws and regulations form the foundation of the system and requirements for development of drugs, biologics, and devices, gaining approval and ongoing responsibilities after marketing. It is not always easy to interpret or apply these requirements to specific projects. To assist with this, the FDA has published hundreds of guidance documents to share their current expectations and best practices. This mass of information can be time-consuming to wade through, form strategic plans, and practical implementation tactics.
This workshop will explain the overall structure of FDA’s regulatory system and how to interpret and best use the plethora of information available to support your development program. Hands on activities for practical application will be used to stimulate discussions and reinforce learnings.
- Overview of FDA’s Regulatory Structure of Laws, Regulations, Guidelines, and other useful knowledge
- Overview of major differences in foundational requirements for drugs, biologics, & devices
- Practical Application Activity
- Navigation of the FDA Website to efficiently use as a resource tool to find information
- Deep dive into the FD&C Act and the PHS Act
- Deep dive into IND regulations for Drugs & Biologics, including importance of the preamble
- Deep dive into IDE regulations for Devices
- Deep dive into marketing applications for drugs & biologics