Pearls of Wisdom
Cures Act plans to speed up drug development through ‘Innovation Initiative’
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...
Is FDA really too slow?
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 contribution to the...
Gretchen Bowker to lead session at 2017 RAPS Convergence
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 Marketing,"...
FDA Commissioner promises elimination of orphan drug designation requests backlog
Commissioner Scott Gottlieb promised to eliminate the backlog of orphan drug designation requests following a June 20th Senate hearing on President Donald Trump’s FY2018 budget request for the US Food and Drug Administration (FDA). Gottlieb stated that he will soon...
BioCrossroads competition encourages entrepreneurial activity of Indiana life science companies
The BioCrossroads New Venture Competition, an early stage business competition designed to encourage entrepreneurial activity of Indiana life sciences and health information technologies, is now accepting applications at www.biocrossroads.com. Since 2012, the...