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AstraZeneca received good news Friday when a key European committee recommended approval of its new drug to treat opioid-induced constipation and a diagnostic test that can help identify patients for its cancer drug Iressa. Read More
Patients will be invited to participate in scientific discussions on the benefits and risks of certain drugs in Europe, under a new European Medicines Agency pilot project. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
India’s Central Drugs Standard Control Organization has issued a uniform set of procedures that state drug authorities should follow when inspecting facilities for good manufacturing practices and issuing certificates of pharmaceutical product. COPPs are required for drugs intended for export. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on good manufacturing practices. Read More
The FDA slammed Cipher Pharmaceuticals for an email that contains overblown superiority claims promoting a cholesterol drug, the latest signal this year that the agency is scrutinizing drugmakers’ electronic promotions. Read More
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow. Read More