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The House Freedom Caucus compiled a broad list of over 200 federal regulations that they would like to see President-elect Donald Trump repeal within his first 100 days in office, including an FDA final rule banning 24 drugs from the market for being unsafe or ineffective. Read More
Director Janet Woodcock laid out her priorities for the coming year, in the wake of the 21st Century Cures Act becoming law earlier this week. Read More
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 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
President Barack Obama signed the 21st Century Cures Act into law during a White House ceremony Tuesday, following over two years of work on Capitol Hill. Read More
Indian drug regulators in seven states have accused 18 drugmakers of selling substandard therapies after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities of active ingredients. Read More
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Read More