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Tag Archive: EU
Bart’s Corner: EU Regulatory Updates
EMA Working Programme for 2014 In December 2013, the EMA published its work program for 2014. It covered the many areas that the agency supervises and regulates. Much of the document is devoted to GMP, operational issues and other non-PV areas. But some comments in the PV sections are of[…]
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Safety Items in the News
Several safety items have been in the news recently and are summarized here. Direct-To-Consumer Safety In February the FDA published a notice in the Federal Register (see: https://telerx.bz/4q) entitled: “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements”. The FDA is requesting comments within 60 days. This is[…]
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