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).
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.
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.
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problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA.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the threshold at which increasing the dosage of a drug product provides no additional clinical benefit, according to a draft guidance released last week.