FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance: - FDA has not changed the requirements, per say. They have split the requirements so there is clarity... Read more
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. This is an... Read more
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing the importance and significance of Guidance Documents for not only life sciences companies,... Read more
Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang. As many of us industry insiders have known for some time, FDA has been planning changes to their regulation and... Read more
The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more
Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more
January 26 is the deadline for compliance with the Customs Border Protection Importer Security Filing (ISF) program. The following Regulatory Alert provides more details on this new program. If your company imports products or materials into the United... Read more
