On November 21, 2022, the FDA’s Center for Food Safety and Applied Nutrition issued warning letters to five manufacturers of food and beverages containing cannabidiol (CBD). These letters mark the […] Read More >>
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>
To be used in foods and dietary supplements, ingredients must: be determined to be Generally Recognized as Safe (GRAS), be approved as a New Dietary Ingredient (NDI), be considered an […] Read More >>
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] Read More >>
This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>
Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical […] Read More >>
In response to the COVID-19 pandemic, Health Canada implemented in March and April 2020 interim measures aimed to facilitate the importation of products that can help to limit the spread […] Read More >>
The COVID-19 pandemic has precipitated an unprecedented public health situation in the United States of America, disrupting supply chains and creating shortages of products aimed at preventing infection. As a […] Read More >>
Software is used extensively in medical devices for gathering, monitoring, and transmitting data to healthcare professionals and clinical technicians. Although software can be an extremely useful tool as a medical […] Read More >>
ISO Prepares for FDA’s Proposed Overhaul of Medical Device Quality System Regulation Late in February 2018, the FDA announced that as part of global harmonization efforts around quality management systems, […] Read More >>
On August 17, the industry comment period for the FDA’s Medical Device Safety Action Plan closed. Back in April of this year, the FDA announced the new Plan, which is […] Read More >>
Failing to conduct proper regulatory due diligence can be likened to failing to conduct a proper home inspection before purchasing a home. We have all heard of home buyers who […] Read More >>
The global veterinary and animal equipment market is growing with an estimated compound annual growth rate (CAGR) of 8.0% in this 2015 to 2020 time period. This growth is largely […] Read More >>
The Food Safety Modernization Act (FSMA) reaches across the entire food industry, not just conventional foods. Stakeholders and consumers rarely think of dietary supplements as foods, even though they are […] Read More >>
    The definition of blood pressure and its associated guidelines have recently been updated in the United States. Previously, high blood pressure was defined by the threshold blood pressure […] Read More >>
  Service(s) related to this article:  Dietary Supplement Consulting, Food Compliance Consulting, New Dietary Ingredients FDA has scheduled a public meeting on October 3, 2017 to discuss developing a list […] Read More >>
    Service(s) related to this article:  Food Safety & Quality, FSMA Consulting Services FDA issues new guidance documents for several items under Food Safety Modernization Act (FSMA) If you […] Read More >>
  Service(s) related to this article:  510K & Canadian Medical Device Consulting As you are planning the commercialization of a new medical device for the US market you will want […] Read More >>