We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. 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 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