Resources for Food and Drug Administration (FDA)

FDA Deadlines May Affect Drug Safety

houston.injuryboard.com

According to a study published in the New England Journal of Medicine deadlines for response to new drug applications may be causing the agency to make hasty decisions. The study suggests that drugs approved closer to the deadline end up having more safety issues once on the market than drugs that are approved earlier in the process. The study shows that of the 97 drugs that were approved within two months of the deadline since 1993, 14 percent went on to be associated with serious safety problems. Of the 216 other drugs that were approved earlier in the 10-month approval window only 3 percent ended up being associated with serious safety problems.

View the Resource

Share or bookmarklet this web page at: