new safety information

new safety information

Information on a drug derived from a clinical trial, an adverse event report, a post-approval study, peer-reviewed biomedical literature, from the post-market risk identification and analysis system (REMS) or other scientific data, regarding:
(a) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed; or
(b) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy.
References in periodicals archive ?
A NEW safety information resource is being made available for the first time to scooter riders in the UK.
A proposed Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to providers and patients by allowing generic drug makers to use the same process as brand-name drug manufacturers to update safety information in the product labeling.
Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.
The second edition includes new safety information and new chapters on resistive-capacitive circuits, and resistive-inductive-capacitive circuits.
Patient safety is central to our public health mission, and FDA is committed to delivering new safety information to nurses and other clinicians at the point-of-care in order to reduce the risk of drug or device-related harm, improving patient health outcomes.
The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of a review of seven epidemiologic studies.
The FDA announced it has acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide) Injection, a drug used to treat type 2 diabetes.
The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.
The TM for the AN/PEQ-15 advanced target pointer illuminator aiming light (ATPIAL) has been updated with new safety information and revised weapon mounting procedures.
This new safety information has been added to the nevirapine package insert, which is available at viramune.
Food and Drug Administration (FDA) is currently evaluating the anti-cancer agent, temsirolimus, for "Potential Signals of Serious Risks / New Safety Information.