Tags FDA

FDA

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

8/6/18--The U.S. Food and Drug Administration issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance issued outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. Furthermore, this new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT. Read

FDA pursues unproven cancer claims

12/19/17--Four companies have received FDA warning letters for selling products online that agency officials said made unproven anticancer claims and contained a component of the marijuana plant. The products reportedly contained cannabidiol (CBD), which isn’t FDA approved for any indication. Read

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

7/28/17--The U.S. Food and Drug Administration announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. Read