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The third phase of restructuring at the Office of New Drugs is underway, setting up an Office of Nonprescription Drugs and an Office of Specialty Medicine. Read More
“The companies engaged in reckless behavior and need to be held accountable for their role in creating the nation’s worst manmade public health crisis,” state attorney general Mike Hunter said. Read More
A congressional committee may be planning to throw its weight behind “complex generics” as part of a push to increase generic options and lower drug costs. Read More
The Government Accountability Office (GAO) laid out policy options for dealing with the challenges of machine learning in drug development in a report released yesterday — noting that uncertainty about potential regulation of machine learning is hindering its adoption. Read More
Health insurers filed a class action suit against Gilead in a Florida federal court accusing it of anticompetitive behavior over its HIV treatments. Read More
Opioid distribution data recently released by the Drug Enforcement Agency (DEA) shows an additional 24 billion opioid pills were distributed in the U.S. between 2013 and 2014 than was previously known. Read More
The Senate voted 89-10 yesterday to pass the United States-Mexico-Canada trade agreement, sending it to the president’s desk as generic and biologic drug advocates cheered the removal of a 10-year biologic exclusivity provision. Read More
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