Search Results for safety labeling

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FDA Makes Drug Safety Labeling Change Information Easier to Access By Zachary Brennan - Published 01 September 2016

The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats.

Categories: News, US, FDA, Drugs, Labeling

Tags: safety labeling changes, CDER database, MedWatch

FDA to Release Major Generic Drug Labeling Rule in July 2016 By Zachary Brennan - Published 03 December 2015

The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Ethics, Government affairs, Labeling

Tags: generic drug labeling, FDA, drug labels, safety labeling