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Former FDA Commissioner Lester Crawford will have to pay nearly $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.
An advisory panel has recommended against FDA approval for an implantable heart-monitoring device until the sponsoring firm can conduct a larger trial.
AdvaMed has reached an agreement with the FDA on user fees through negotiations on the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
The FDA ordered 20 companies to stop manufacturing unapproved drug products containing ergotamine tartrate as part of the agency’s safety efforts to keep unapproved drugs off the market.
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.
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 defended the agency’s budget proposal for 2008 to Congress, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews.