Blog
HHS investigates FDA in 2016
According to Zachary Brennan of RAPS, The U.S. Department of Health and Human Services Inspector General will be investigating FDA on post-marketing requirements, supply chain exchanges, hospital medical device oversight, and three additional programs on food and...
Pearl Pathways announces new partnership with greenlight.guru
We are excited to announce a strategic alliance with eQMS service provider, greenlight.guru. This partnership will allow clients to adapt to changing technologies while improving their regulatory processes through shortened time to market and risk reduction. Pearl...
Income differences driving participation in clinical trials?
Mary Engel, writer for Fred Hutch News Service, stated the importance of clinical trials and patient involvement in her recent article. Participation in clinical trials is crucial to the development and success of finding new treatments because they are currently the...
ACRP fall symposium on November 6
On November 6th, the ACRP will be hosting their 15th annual fall symposium at the Sheraton Hotel in Indianapolis. Pearl Pathways will be exhibiting at the event, while Pearl Pathways’ Gretchen Bowker will be speaking on FDA audit tips. Mary Anne Gfell and Patti Hunker...
FDA bans API manufacturer after 483
According to Zachary Brennan’s article on RAPS, an Indian active pharmaceutical ingredient (API) manufacturer, Megafine, was banned from FDA after a 483 inspection. Other regulators around the world have approved the company; however that may change soon. The notes...