by Michele Taylor | Feb 3, 2016
The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about...
by Michele Taylor | Feb 2, 2016
Making it easy for you to keep up on the latest and connect with us, we recently launched the @PearlPathways twitter account. Please follow us here @PearlPathways. As always, we welcome the opportunity to partner with you — please contact us to talk about your...
by Michele Taylor | Jan 29, 2016
On February 17-18, 2016 the Diversity Alliance for Science (DA4S) conference will be held at the Marriott Long Beach Airport Hotel, in Long Beach, CA. DA4S is a non-profit organization focused on supporting, developing, and connecting with a diverse group of suppliers...
by Michele Taylor | Jan 27, 2016
The complex issue of testing for bioequivalence was covered in a recent article by Phil Taylor, In-pharma. It is recognized that the FDA has the very complex job of determining bioequivalence of generics to innovator products. Physicians and patients rely on FDA...
by Michele Taylor | Jan 22, 2016
The House Appropriations Committee announced the Omnibus Appropriations bill providing the FDA more funding this year for medical product safety initiatives. Funding is also directed to the Combating Antibiotic Resistant Bacteria (CARB) initiative, the Precision...
