In what year was the Generic Drug Enforcement Act passed?

In what year was the Generic Drug Enforcement Act passed?

• A. 1984
• B. 1987
• C. 1994
• D. 2000

Answer: (A)

The Generic Drug Enforcement Act was indeed passed in 1984. This legislation was significant as it aimed to establish standards for the approval of generic drugs and addressed issues related to the submission of falsified drug applications. Prior to this act, there was increasing concern over the integrity of the drug application process, leading to an emphasis on the need for strong regulations regarding the marketing and manufacturing of generic drugs. The act not only set forth the requirements for generic drug applications but also provided the FDA with the authority to impose penalties against firms that engaged in fraudulent behavior regarding generics. This established a framework that has shaped the generic drug market significantly since then.

The Generic Drug Enforcement Act was indeed passed in 1984. This legislation was significant as it aimed to establish standards for the approval of generic drugs and addressed issues related to the submission of falsified drug applications. Prior to this act, there was increasing concern over the integrity of the drug application process, leading to an emphasis on the need for strong regulations regarding the marketing and manufacturing of generic drugs. The act not only set forth the requirements for generic drug applications but also provided the FDA with the authority to impose penalties against firms that engaged in fraudulent behavior regarding generics. This established a framework that has shaped the generic drug market significantly since then.