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Andrea Young

Andrea Young

Andrea Young is the Supervisor of Regulatory Compliance at Alcami. She has over 18 years of experience in the pharmaceutical industry, and has spent nine years providing both internal and external support for regulatory related matters. She also has considerable experience in Quality. Andrea has a Bachelor of Science degree in Biology from St. Bonaventure University, and an MBA from the University of North Carolina Wilmington.

Recent Posts by Andrea Young:

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 a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Topics: Thought Leadership Regulatory Compliance Drug Product Orphan Drugs