NEWS & EVENTS
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:

505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). A 505(b)(2) application is a hybrid between the FDA's traditional NDA and an abbreviated new drug application (ANDA). These submission types were made possible in 1984 by the adoption of the Hatch-Waxman Act. The act was created to allow for generic competition and increased innovation in the pharmaceutical arena. A true generic or ANDA demonstrates that the drug is identical to an already approved product based on bioequivalence data and chemical equivalence. 

Topics: News & Events Regulatory Compliance Blogs 505(b)(2)

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: Regulatory Compliance Drug Product Orphan Drugs Blogs