Why Drugs and generics are Approved while Biologics are Licensed ?

S

SGquality

Quite Involved in Discussions
The Drugs and Generics are approved by NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) while Biologics have a BLA (Biologics License Application) and are Licensed.

What is the difference between "Approved" for Drug products and "Licensed" for Biological products ?
 
Ajit Basrur

Ajit Basrur

Leader
Admin
SGquality said:
The Drugs and Generics are approved by NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) while Biologics have a BLA (Biologics License Application) and are Licensed.

What is the difference between "Approved" for Drug products and "Licensed" for Biological products ?
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Because biological products are licensed under section 351 of the Public Health Service (PHS) Act.

refer the FAQ here for more info - http://www.fda.gov/Drugs/Developmen...TherapeuticBiologicApplications/ucm113522.htm
 
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