Rules Adopted to Speed Drug Approval
WASHINGTON — The government has published new regulations for reviewing the safety and effectiveness of prescription drugs that it said could cut six months from the two or more years now required to approve new drugs for the market.
Margaret M. Heckler, secretary of health and human services, called the new procedures “the most important change in FDA drug regulations in more than 20 years.”
The regulations, published Friday, will govern procedures of the Food and Drug Administration in determining the safety and efficiency of drugs that pharmaceutical companies hope to market to the public.
Heckler released the regulations in December, but publication in the Federal Register is a required step to putting them into effect. They will go into effect in 90 days.
At present, applications for approval of new drugs average about 100,000 pages in length and require two or more years from review to approval, Heckler said. The revised rules could reduce the paperwork by 70% and shorten the review by as much as six months, she said.
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