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Trionix Research Laboratory neglected to perform device change procedures on a faulty product and did not inform the FDA of the malfunction, a recent agency warning letter said.
The quality systems requirements the FDA is now mandating for drugs and biologics have been in place for the medical device industry since 1997, according to experts speaking at the recent Compliance Boot Camp in Las Vegas.
Beginning this month, each issue of Drug GMP Report will include a four-page PharmaDevice IT Report supplement. So, in addition to the information on industry best practices and advice on drug manufacturing issues you’re used to getting with DGR, you will also receive information on FDA actions on Part 11 and other technology initiatives from the agency and other government offices.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to be the FDA commissioner was successful as the Senate voted overwhelmingly Dec. 7 to approve the nomination.
Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, and one of the agency’s more public faces, is going back to the private sector in January, the agency announced.
The FDA is now imposing the quality systems thinking that has been a staple of the medical device industry since 1997 on manufacturers of drugs and biologics, according to experts speaking at the recent Compliance Boot Camp in Las Vegas.
Patients implanted with drug-eluting stents who have not had cardiovascular events or additional procedures within six months of follow-up may benefit from extended use of the blood-thinning drug clopidogrel, according to a study to be published in the Jan. 10 issue of The Journal of the American Medical Association (JAMA).