The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices. Reducing drug prices was
FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties
On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent properties. The FDA’s