You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] Read More >>
In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier […] 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 >>
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 >>
  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:  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 >>
This is an article taken from the official FDA U.S. Food and Drug Administration website. The U.S. Food and Drug Administration is amending a regulation that authorizes a health claim […] Read More >>
This is an article taken from the official FDA U.S. Food and Drug Administration website. FDA Issues Draft Guidance for Industry for Voluntarily Reducing Sodium UPDATE The FDA is extending the […] Read More >>
This is an article taken from the official FDA U.S. Food and Drug Administration website. FDA Issues Final Rule on Food Ingredients that May Be “Generally Recognized as Safe” In […] Read More >>
This is an article taken from the official FDA U.S. Food and Drug Administration website. The following is a press announcement from FDA of interest to our Constituent Update subscribers. […] 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 >>
Companies marketing dietary supplements aim to make claims for their products in order to help successfully market their products/product lines. As such, claims being made for dietary supplements are a […] Read More >>
July 24, 2015 – FDA provides supplemental proposal for changes to the Nutrition Facts panel to require % DV for sugars. The U.S. Food and Drug Administration is proposing additional […] Read More >>
  June 2015 – FDA announces Partially Hydrogenated Oils (PHOs) are no longer GRAS. Industry has until June 28, 2018 to remove from products In November 2013, FDA posted a […] Read More >>
  USDA’s Process Verified Program verifies facility process of manufacture can ensure products do not contain GMO ingredients. This ground-breaking distinction was achieved by SunOpta’s food manufacturing facility in Hope, […] Read More >>
  Requirements for a country of origin to be indicated on meat labels for products imported into the US is currently under repeal, as the WTO approves tariffs on US […] Read More >>
As of late DNA Barcode testing has been a subject of heated debate, which can be a valuable tool when used appropriately. However, the appropriateness of its use is up […] Read More >>
Cosmetic compliance and safety falls under the purview of the FDA. They have recently provided information to improve oversight with respect to microbiological safety. While the FDA does not currently […] Read More >>