Merck Threat for Missing Study May Be Wider Warning to Industry

The FDA has warned Merck that it could face fines for being months late on two postmarket study deadlines to assess acute pancreatitis risk with diabetes drugs Janumet and Januvia. The move appears to be the first time the FDA has invoked its new enforcement authority for postmarking requirements granted under the 2007 FDA Amendments Act and may signal a new trend at the agency, Kurt Karst an attorney at Hyman, Phelps & McNamara, wrote in his FDA Law Blog.
Washington Drug Letter