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The FDA and the HHS Office of Human Research Protections published a joint guidance on the use of electronic informed consent, containing recommendations for meeting both agency’s regulations. Read More
Generic approvals and rejections were little changed from last month, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Read More
The FDA has faulted Sanofi and Celgene for running misleading TV advertisements for two of their drugs and ordered the companies to pull the commercials. Read More
The Association of the British Pharmaceutical Industry found five drugmakers — AstraZeneca, Eli Lilly, Janssen, Boehringer Ingelheim and Grünenthal — violated the trade group’s code of practice by engaging in activities that ranged from deceptive marketing to inaccurate training. Read More