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 ?
In November 2015, an FDA Advisory Committee discussed the risks and benefits of fluoroquinolones for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections based on new safety information.
The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information.
The FDA says it will release in July a controversial and major final rule that would allow generic drug companies to up date their labels with new safety information like their reference product counterparts have done for almost 30 years.
55) The proposed amendment addresses safety concerns about unilateral label changes for generic drugs by permitting the FDA to send a request letter notifying the brand-name manufacturer of the new safety information.
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.
Persuasive language is used to convey new safety information to health care professionals who, in turn, will advise or monitor patients.
The second edition includes new safety information and new chapters on resistive-capacitive circuits, and resistive-inductive-capacitive circuits.
In May 2010, the FDA revised prescription and over-the-counter (OTC) labels for proton-pump inhibitors to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with use of these medications.
The resubmission also included a final safety update that provided updated or new safety information on patients in clinical studies who have been treated with Horizant.
In May, the Food and Drug Administration (FDA) notified healthcare professionals and patients of revisions to the prescription and over-the-counter (OTC) labels for proton pump inhibitors (which work by reducing the amount of acid in the stomach and are used to treat acid reflux) to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
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.