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Orphan Drugs

QbD Addresses API Supply in Orphan Drug Formulation

According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...

Blog: Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that...

Blog: Formulating for Orphan Indication Drug Products

According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects...

Case Study: Challenges and Solutions to Formulating an Orphan Drug

According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...