Back in 2016, the FDA published new requirements for the Nutrition Facts Table (or NFT) on packaged foods. This update was made to reflect new scientific information, linking together diet […] Read More >>
On January 26, 2023, Principal Deputy Commissioner Janet Woodcock released a statement regarding the current state of cannabidiol (CBD) regulation by the FDA and a growing need for a “new […] Read More >>
On January 31, 2023, the Commissioner of the Food and Drug Administration, Dr. Robert Califf, announced a proposal to overhaul the human foods program to protect food safety. The statement, […] Read More >>
The FDA has recently announced a proposal to amend the current Investigational New Drug (IND) application regulations. The proposal involves 2 exemptions for clinical investigations involving lawfully marketed foods (including […] Read More >>
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 >>
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 >>
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