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FDA sees some drug delays amid safety focus

SILVER SPRING, Maryland
Tue May 27, 2008 2:13pm EDT

SILVER SPRING, Maryland (Reuters) - A new focus on drug safety is delaying the approval of some medicines as regulators impose requirements meant to minimize side effects, a top U.S. drug regulator told Reuters on Tuesday.

The Food and Drug Administration gained new powers in March to require distribution limits or other restrictions on the sale of new medicines.

"That's taking a considerable amount of time more for every application. That will go away in time," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview with Reuters.

At present, the process is adding days or weeks to reviews of drugs that need the additional safety measures, she said.

Woodcock also said the agency was concerned about the safety impact of the growing number of clinical trials being conducted outside the United States by drugmakers.

(Reporting by Lisa Richwine and Susan Heavey; editing by John Wallace)



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