Providing Guidance on generic ADF development

In March 2016, the FDA issued draft guidance to assist potential applicants in developing a generic version of an oral opioid drug product seeking abuse-deterrent properties described in its labeling. This is an important step to encourage the development of abuse-deterrent prescription opioids.



Download the draft
guidance here



On October 31 and November 1, 2016, the FDA held a public hearing to gather feedback and input to the draft guidance and invited all stakeholders, including developers and manufacturers of abuse-deterrent technology and products, to contribute to the advancement of the draft guidance, which is expected to be issued within the next few months.



Read the draft
guidance here