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.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM475586.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 


 

FDA – Industry – Academia Fellowships

fellowship

Interested ? http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM426710.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery


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)

WHERE :  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

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