IntroductionOrphan drug designation is a status given to drugs and biologics intended to treat rare diseases or conditions. It offers several benefits, including tax credits, market exclusivity, and assistance with clinical trial design. Understanding when to apply for this designation is crucial fo...
Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes the importance of designing quality into the product from the very beginning. This method integrates scientific understanding and risk management to ensure that the final product meets its intended quality...
The FDA Orphan Drug Designation application is a critical process for pharmaceutical companies and researchers looking to develop treatments for rare diseases. This designation, granted by the U.S. Food and Drug Administration (FDA), provides various benefits to encourage the development of drugs fo...
