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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
The FDA warned Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel, but the company says its labeling can back up the claims. Read More
British regulators have revised their recommendations on the reporting of pediatric adverse drug reactions to focus on severe or serious events, a change that addressed complaints that the previous system was overly burdensome. Read More
Clinical studies to evaluate drugs treating irritable bowel syndrome (IBS) should involve patients experiencing recurrent abdominal pain or discomfort at least three days per month in the previous 90 days, according to new final guidance issued by the European Medicines Agency. Read More
Boehringer Ingelheim won FDA approval Thursday for its chronic obstructive pulmonary disease (COPD) drug Spiriva Respimat and plans to launch the drug by the new year. Read More
With patent expirations looming, AbbVie secured a new indication for its blockbuster biologic Humira to treat children suffering from moderate to severe Crohn’s disease. Read More
Shire agreed to pay the federal government $56.5 million to settle allegations it peddled outlandish superiority claims for its attention deficit disorder drugs, including a sales pitch that Adderall XR could prevent poor school grades and traffic accidents. Read More