August 21, 2019
After decades in the pharma, device, and biologics industry working in new product development and manufacturing quality; market quality and post market surveillance; and quality systems my answer can be summed up in one word. Watermelon. yes, watermelon. Why watermelon? Today’s drive to measure, measure, measure has yielded a culture of creating metrics that will […]
April 22, 2019
By now, most everyone in FDA regulated industry is aware of Theranos, the Wall Street Journal’s John Carryrou, and his award-winning book Bad Blood: Secrets and Lies Inside a Silicon Valley Startup. But have you seen HBO’s new documentary, “The Inventor: Out for Blood in Silicon Valley?” I was lucky enough to come across the […]
February 27, 2019
FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance There is a high degree of value in working closely with FDA from pre-clinical Development through Clinical Development to ensure successful PMA applications approval in a timely manner. FDA has taken many steps to increase […]
February 22, 2019
Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce… A critical Guidance has been issued by FDA; the new Guidance, “Refuse to Accept Policy for 510(k)s”, is now available on fda.gov. Refuse to Accept Policy for 510(k)s This is an important Guidance document for all firms intending to file 510(k) s […]
February 15, 2019
Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding “non-binding feedback” after FDA inspections of certain medical device establishments. Navigating FDA Guidance on Public Health Priorities Limited to statutory (FDARA 704) situations involving a “public health priority”, “implicat[ion] of systemic or major actions” or “relat[ing] to emerging safety issues (as determined by [FDA])”, this […]
February 7, 2019
Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships with consulting firms or solo consultants. The sheer volume of options in 2019 can make your head […]
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