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Former FDA Commissioner Lester Crawford will have to pay $90,000 in penalties and serve three years of probation for federal fraud charges levied against him for failing to disclose financial conflicts of interest and making false statements, his attorney said.
FDA Commissioner Andrew von Eschenbach made his second appearance in two days before Congress to support the agency’s proposed 2008 budget, but he also had to defend the agency’s handling of Ketek and other controversial topics.
FDA Commissioner Andrew von Eschenbach defended the agency’s budget proposal for 2008 to a Senate subcommittee, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews.
The FDA approved Shire’s amphetamine-based attention-deficit/hyperactivity disorder (ADHD) drug Vyvanse, which has a lower risk of abuse than similar drugs, the company announced.
Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
Corin has overcome several obstacles -- including patients refusing to participate in the control arm of a clinical study testing its joint device -- to gain a favorable FDA advisory committee panel vote of 41 recommending that the agency allow the firm to market its device.
Americans who attempted to purchase certain drugs over the internet instead received products containing haloperidol, a strong anti-psychotic drug, the FDA said.