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 >>
  Service(s) related to this article:  Dietary Supplements Dietary supplement use is a growing sector with unique regulatory requirements. dicentra’s dietary supplement consulting can help get you on the road […] Read More >>
The original article is found here. The Food and Drug Administration (FDA) is charged with oversight over cosmetics. However, unlike other products FDA regulates, such as drugs, foods, and tobacco, the […] Read More >>
This is an article taken from the official FDA U.S. Food and Drug Administration website. FDA Extends Certain FSMA Compliance Dates; Issues Draft Guidance The U.S. Food and Drug Administration […] Read More >>
It’s been 5 years since you’ve first started hearing about looming FSMA deadlines. Now that the first deadline for 2016 has arrived, its time for you to understand how this […] Read More >>
An article taken from the FDA website concerning sugar substitutes – found in some human foods and dental products that can be poisonous to your dog. Original Article Found On: […] Read More >>