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What do the Pediatric Rule states?

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What do the Pediatric Rule states?

(a) No drug should be tested on children

(b) No separate drug for children

(c) Include usage of pediatric use of a product

(d) Advertise the pediatric usage

This question was posed to me by my school principal while I was bunking the class.

The doubt is from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology

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The correct answer is (c) Include usage of pediatric use of a product

Easy explanation: Under the Pediatric Rule introduced in 1998, companies introducing new active ingredients for biologics and drugs, and new dosage forms or indications for existing biologics and drugs, are supposed to assess the effects of the drugs in children and include information about pediatric use of the product in their post-marketing reports.

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