News|Articles|May 23, 2017

Gottlieb Outlines Opioid Fight

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.

On May 23, 2017, FDA Commissioner Scott Gottlieb, MD, posted a blog post detailing his plans to fight the opioid addiction crisis, including a new steering committee. The commissioner also asked his staff for their input on how to combat this important health issue.

One of the first parts of the agency’s plan is the creation of the Opioid Policy Steering Committee, which will consist of FDA senior leaders. The committee is charged with reviewing the need for education for healthcare professions, the possible tailoring of the number of dosages, and the agency’s framework for assessing opioid abuse.

“Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic,” Gottlieb stated in the blog post.

Source: FDA


Related to this article

Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Complying with International Pharmacopoeias
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 2
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.