Best Practices for IND Sponsor-FDA Meetings

FDA best practicesSummarizes 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


Interested ?

Purple Book

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)



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