Regulatory Terms Starting With O

3 terms in the O index.

• Orange Book (Orange Book)

  Orange Book is FDA's published list of drug products approved as safe and effective under the Federal Food, Drug, and Cosmetic Act, paired with therapeutic equivalence codes and the patent and exclusivity information that governs generic entry.

• Orphan Drug Designation (ODD)

  Orphan Drug Designation is an FDA status, not an approval, granted to a drug for a disease affecting fewer than 200,000 people in the United States, carrying seven years of marketing exclusivity if the drug is later approved.

• Out of Specification (OOS)

  Out of Specification (OOS) is a laboratory test result that falls outside an established specification or acceptance criterion, obligating a documented investigation and a batch disposition decision before the material can be released.