Orphan Drug Designations (ODD)

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) provide specific incentives to companies who are granted ODD for their product.

 

BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your European Medicines Agency (EMA) / Food and Drug Administration (FDA) application.

 

 

 

Our experts

Associated News

The French system for preventing and managing shortages

The French regulation on the prevention and management of stock shortages of medicinal products is...

Learn more

FDA GUIDANCE – COVID-19

BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...

Learn more

EMA GUIDANCE – COVID-19

Given the support given to our clients in interactions with health authorities all around the...

Learn more

Register Now for our Next BlueReg Webinar !