Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

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What additional protection is granted for pediatric studies under the FDA Modernization Act of 1997?

Six months patent protection
Two years patent protection
Exclusive marketing rights
Priority review status

The correct answer is: Six months patent protection

The FDA Modernization Act of 1997 granted additional protection for pediatric studies in the form of six months patent protection. This means that after a drug or treatment has been approved by the FDA, the manufacturer has an additional six months of exclusive rights to sell the drug before generic versions can be produced. This incentivizes pharmaceutical companies to conduct more studies on the safety and efficacy of their products for use in pediatric patients. Option B, two years of patent protection, is incorrect because it offers a longer period of protection which may not be necessary or practical for pediatric studies. Option C, exclusive marketing rights, is incorrect because it does not specifically address the protection granted by the FDA Modernization Act for pediatric studies. Option D, priority review status, is incorrect because while it may expedite the review process for pediatric studies, it does not offer additional protection in terms of patent rights.