WASHINGTON—The Food and Drug Administration has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official.
The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years.
In testimony before the House Energy and Commerce's health subcommittee, Janet Woodcock, the head of the FDA's drug division, responded to some lawmakers concerns that a tougher safety stance taken by the agency was slowing down the pace of drug approvals and hurting the pharmaceutical and biotech industry.
FDA's drug approval figures involve drugs or biologics—which are made from living cells—that are considered new types of products. They don't include approvals granted for new formulations or new uses of existing drugs as well as vaccines.
Ms. Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications. In other cases companies are asked to submit more information, which prompts additional reviews, or drugs are rejected.
For More Information please use the below weblink: The Wall Street Journal - FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010
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