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 […]
April 5, 2018
As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me. Unfortunately, this is not the first time this topic has been discussed. There are frequent speakers these days berating “compliance” in favor […]
January 30, 2018
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory guidance for agency practice by substantially reducing the importance and significance of regulatory Guidance Documents for not only life sciences companies, but all industry segments. Although ironically the policy position was itself not effectuated by […]
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