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Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at a recent FDAnews audioconference.
Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined for fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the Office of Regulatory Affairs.
The FDA will hold a public hearing on improving distribution of medication guides with risky medications after a lawmaker questioned the guides' distribution system, the agency announced. Read More
GlaxoSmithKline (GSK) and Adolor stopped development of their bowel-disorder drug and withdrew an application because of increased risk of heart attacks, benign and malignant tumors and bone fractures, the companies said.
An increased risk of side effects from Merck’s potential Vioxx successor Arcoxia indicates the drug should not be approved unless it fills an unmet need, an FDA employee told an advisory committee.
Individual adverse events in clinical trials are not necessarily the same thing as unanticipated problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA.
The FDA is recommending that manufacturers identify in physician labeling the threshold at which increasing the dosage of a drug product provides no additional clinical benefit, according to a draft guidance released last week.
The FDA ordered companies to stop manufacturing unapproved suppository products containing trimethobenzamide hydrochloride because the drugs lack proof of efficacy.
The FDA is advising Newport Medical Instruments to include corrective actions instituted to resolve continuing complaints regarding the battery life for its HT-50 Homecare ventilators in the firm’s response to a recent warning letter.