FDA Joint Meeting of DSaRM & AADPAC


Today, Dr. Nabarun Dasgupta will give a guest presentation  on the Overview of Evaluating ADFs in the Community at the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).

Learn more about the entire meeting:

The presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OXYCONTIN (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OXYCONTIN. The committees will discuss whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OXYCONTIN product has resulted in a meaningful reduction in these outcomes. The committees will also discuss the broader public health impact of OXYCONTIN’s reformulation.

To view the webcast of the discussion, visit this link (Adobe Connect) where the FDA has provided additional information. Materials for the committee meeting can be found here.