Demonstrating that your generic drug is therapeutically equivalent to the reference drug is essential in submitting a successful Abbreviated New Drug Application (ANDA) in the USA.
You can choose to use different types of evidence to show this, including in vivo or in vitro testing, or both. But to help you select the most appropriate method for your particular drug, the US Food and Drug Administration (FDA) has a range of product-specific guidances.
The FDA has been reviewing these documents over recent months and 46 product-specific guidances were updated and finalised on 4 August 2017. The guidances can be accessed here.
If you would like advice or assistance with your generic application in US or EU, please contact the Regulis team.