by Maya Caldwell | Jul 18, 2017
Monday, July 10th, the US Food and Drug Administration (FDA) finalized a list of 1,003 types of class II medical devices that do not present risks requiring premarket notification review to provide assurance of safety and effectiveness. The list was created under the...
by Maya Caldwell | Jul 17, 2017
The 21st Century Cures Act, signed into law on December 13th, 2016, plans to speed drug development through an “Innovation Initiative,” according to FDA and its commissioner Scott Gottlieb. Gottlieb recently wrote on the blog FDA Voice: “FDA will soon unveil a...
by Maya Caldwell | Jul 13, 2017
The US Food and Drug Administration (FDA) is consistently ranked among the world’s fastest regulators. Yet, it is often critiqued for being too slow. Two researchers attempt to debunk these claims. “This crude depiction ignores industry’s...
by Maya Caldwell | Jul 13, 2017
Gretchen Bowker, co-founder and COO of Pearl Pathways, will lead a session of the Health-Related Foods Track at this year’s RAPS Convergence in National Harbor, MD. The session, titled “Functional Foods and Dietary Supplements: Manufacturing, Claims, and...
by Maya Caldwell | Jun 28, 2017
Biosimilar companies will no longer have to wait an additional six months after FDA approval to launch new biosimilars. This is due to a unanimous decision by the US Supreme Court. The case set biologics manufacturer Amgen against Novartis subsidiary and biosimilar...
