Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Source: Drug Industry Daily

The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes…

The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 conference…

The PTO’s Patent Trial and Appeal Board invalidated several claims relating to the manufacture of the widely used anesthetic Diprivan (propofol), in a patent held by Fresenius Kabi. Source: Drug…