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.
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More
Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More
The FDA still plans on finalizing the highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More