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In March 2016, the FDA issued draft guidance to assist potential applicants in developing a generic version of an oral opioid drug product seeking abuse-deterrent properties described in its labeling.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Download the draft guidance here

 

 

On October 31 and November 1, 2016, the FDA held a public hearing to gather feedback and input to the draft guidance and invited all stakeholders, including developers and manufacturers of abuse-deterrent technology and products, to contribute to the advancement of the draft guidance, which is expected to be issued within the next few months.

 

 

Read the draft guidance here

 

 

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