Simplifying Global Compliance
Articles Tagged with ''FDA''
The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM). Read More
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at a recent FDAnews audioconference. Read More
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. 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. Read More
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. Read More
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problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA. Read More
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the threshold at which increasing the dosage of a drug product provides no additional clinical benefit, according to a draft guidance released last week. Read More
The FDA ordered companies to stop manufacturing unapproved suppository products containing trimethobenzamide hydrochloride because the drugs lack proof of efficacy. Read More
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. Read More
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