The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced. Source:…

The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Source: Drug Industry…

The FDA will revise existing pre-submission draft guidance for ANDAs in light of the passage of the FDA Reauthorization Act of 2017. Source: Drug Industry Daily

The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that…

FDA Commissioner Scott Gottlieb has elevated Rachel Sherman to the No. 2 job at the agency, principal deputy commissioner. Source: Drug Industry Daily

The FDA warned a Chinese drugmaker for inadequate testing and quality control for drug supplies and finished products, as well as numerous other GMP violations. Source: Drug Industry Daily

Insys Pharmaceuticals settled with the state of Illinois for $4.45 million to settle a 2016 lawsuit over the company’s deceptive marketing of opioids, the state attorney general announced. Source: Drug…

The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with…

The FDA will convene a public meeting of its Pediatric Advisory Committee to discuss the use of opioid cough medicines in treating children, part of the agency’s ongoing efforts to…

A New Jersey federal court ruled that a Taiwanese firm infringed on patents held by Maryland-based drugmaker Supernus. Source: Drug Industry Daily