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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 imprecise training. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
The FDA finalized guidance on suspect products and notification, describing when to file a report and adding examples of fraudulent activity that would warrant an alert to the agency, trading partners and wholesale distributors. Read More
The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More
The EMA published a third revision to its guideline for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products. Read More
China’s Food and Drug Administration recently proposed revisions to its good clinical practices guidelines, standardizing the conduct of drug studies. According to the global law firm Ropes & Gray, the revisions are similar to those proposed by the International Conference on Harmonization guidelines. Read More
When instituting electronic informed consent processes, sponsors should present study information in an easily understandable manner and ensure that documentation is legally effective, according to guidance from the FDA and the HHS Office of Human Research Protections. Read More