Best Practices for IND Sponsor-FDA Meetings
Summarizes FDA’s Philosophy
- Timely & interactive
- Scope
- Types
- Expectations
- Best practices
Ideally, IND sponsors and FDA work collaboratively during the drug development process, having a shared public health goal of early availability of safe, effective, and high-quality drugs to the American public.
FDA – Industry – Academia Fellowships
Purple Book
WHAT : To see if particular biological product has been determined by to be biosimilar to or interchangeable with a reference biological product
WHY : User friendly resource for Biologics & Biosimilars (similar to The Orange Book for drugs & generics)