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Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
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