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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 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
As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
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 sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Read More