Regulatory Issues

FDA changes rules on testing drugs for children

Published in Medical Letter on the CDC and FDA, May 19th, 2002

The U.S. Food and Drug Administration is suspending a rule that lets the government require safety testing of adult medicines commonly given to children, a move that has drawn the ire of some Democratic lawmakers.

The reason: FDA says Congress recently reauthorized financial incentives for manufacturers to do those studies. The FDA said it wants to see if the new law makes the old mandate, which drug makers hated, unnecessary.

But three Democrats complained to President Bush that the action was halting "an important regulation that protects children from potentially unsafe and improperly dosed medications."

Adult medications are...

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Source: Medical Letter on the CDC and FDA (2002-05-19)

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