Tag archives: ANDA

FDA releases new guidances on increasing generic drug competition

By on October 12, 2017 Posted in Regulatory

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 a stated objective of President Trump during his campaign and has also been a topic … Continue reading

FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties

By Yvonne Puig (US) and Mark Faccenda (US) on March 25, 2016 Posted in FDA & Food Safety

On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent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 The FDA’s draft guidance follows its April 2015 final guidance for brand name opioids, which marked the … Continue reading