QbD Addresses API Supply in Orphan Drug Formulation
According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...
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Orphan Drugs
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...