PHARMACY

Pace of FDA drug approvals looks to slacken

BY Drew Buono

WASHINGTON The Food and Drug Administration is on pace to approve just 18 new drugs by the end of 2007, according to the Dow Jones Newswires.

Pharmaceutical companies are blaming the FDA for being too cautious in approving new drugs. The agency has been decreasing new drug approvals almost every year since 2004, when Merck withdrew its painkiller Vioxx because of safety concerns.

FDA argues that its criteria for review haven’t stiffened substantially. “There have been no systematic changes in how FDA is approaching the approval standards for new drug applications,” a spokeswoman said. “Each application is reviewed on its own merit and judgments are made by the signatory authority as to whether the application meets the statutory standards.”

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N.J. Rep. criticizes FDA over weaker antidepressant warnings for children

BY Drew Buono

WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.

Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information. 

In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.

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Herbert Luther appointed Perrigo’s VP of global regulatory affairs

BY Drew Buono

ALLEGAN, Mich. Perrigo has announced that Herbert Luther will become the company’s vice president, global regulatory affairs.

In this role, Luther will be responsible for developing and executing regulatory-submission strategies, ensuring best practices, and implementing technologies to enhance efficiency.

Luther has over 20 years experience in the development of regulatory and clinical strategies. Before joining Perrigo, he worked at KV Pharmaceuticals, where he was vice president of regulatory/clinical affairs. Before that, he served as director of regulatory affairs at Barr Laboratories.

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