On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they need by taking steps to facilitate increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. FDA will hold a public meeting on July 18, 2017, to solicit input on this topic, including how standards and procedures related to generic drug approvals are being used in ways that might create obstacles to generic access; how regulatory rules might be “gamed” in ways that may delay generic drug approvals beyond the time frame the law intended in order to reduce competition. FDA is actively looking at ways their rules are being used and, in some cases, misused.
To read the full notice, visit the FDA Voice Blog for the U.S. Food & Drug Administration.
Please refer to the Federal Register notice for information on the public meeting.
We at Phlexglobal provide comprehensive regulatory & clinical solutions. Reach out to us at info@phlexglobal.com for more information on how we can help you.
