Services to Ease FDA Regulatory Compliance

Purple Book For Licensed Biological Products

2

Nov

2016

FDA has published purple book containing list of licensed biological products with reference   product, and biosimilarity.   The lists includes the date on which biological product was licensed under PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

 

This list will enable to see whether a biological product of users interest is determined by FDA to be bio similar or interchangeable. This list will also provide reference product exclusivity expiry date.

You can find purple book at below link.

 

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/

BACK
Translate »