Search Results for label changes

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Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds By Zachary Brennan - Published 08 September 2017

The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found an association between these expedited pathways and the likelihood of safety-related labeling changes.

Categories: News, US, FDA

Tags: breakthrough drug, accelerated approval, fast track, drug safety, label changes

Generic Drug Industry Group Seeks FDA Regulation Changes By Zachary Brennan - Published 25 April 2017

The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug policy, AAM and FDA regulations, label changes for generics

FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines By Zachary Brennan - Published 20 April 2017

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

Categories: News, US, FDA, Crisis management, Government affairs, Labeling

Tags: codeine, tramadol, label changes

New Studies Push FDA to Expand Label for Popular Diabetes Drugs By Zachary Brennan - Published 08 April 2016

Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.

Categories: News, US, FDA, Drugs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: metformin, diabetes, label changes, FDA and safety communications

FDA Requires New Labels for Opioids By Zachary Brennan - Published 22 March 2016

The US Food and Drug Administration (FDA) on Tuesday announced class-wide safety labeling changes for immediate-release (IR) opioid pain medications, which make up about 90% of all opioid prescriptions. The labels now include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.

Categories: News, US, FDA, Crisis management, Drugs, Labeling

Tags: opioid labels, IR opioid labels, label changes, boxed warning