At the NBJ Summit this summer, Dr. Daniel Fabricant, Ph.D., director of the FDA’s Division of Dietary Supplement Programs, was asked his opinion on the status of the dietary […] Read More >>
Since the final good manufacturing practices (GMP) rule for dietary supplements was implemented in 2007, the Food and Drug Administration (FDA) has made it very clear that GMP inspections […] Read More >>
By: Ashleigh Hampton, MSc Manager, Scientific Affairs Supporting evidence is required by both the Canadian and American regulatory bodies to substantiate marketed health claims. Health Canada reviews the evidence to […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York […] Read More >>
By Heather VanBlarcom General Counsel and Senior Regulatory Specialist for Dietary Supplements It’s been no secret that obesity in the United States has been on the rise, largely due, in […] Read More >>
What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Over the weekend, the Chicago Tribune quoted Dr. Daniel Fabricant, head of the FDA’s Division of Dietary Supplement […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements We can breathe a sigh of relief thanks to Senate supplement-industry champions Tom Harkin (D-IA) and Orrin Hatch […] Read More >>
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached […] Read More >>
By Sheldon Baker Nutraceuticals World Published May 18, 2012 Heather Van Blarcom recently joined dicentra and is a licensed attorney with more than 10 years of experience in the natural […] Read More >>
Current Good Manufacturing Practices (cGMPs) for Dietary Supplements have been in effect since June 2010 and the FDA has been increasing inspections each year since. In 2011, 145 FDA inspections […] Read More >>
William Morkel, BSc Director of Quality and Compliance, dicentra If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, […] Read More >>
By Arwen Brooks Quality Assurance and Regulatory Affairs Assistant, dicentra Dec. 15, 2010 — The FDA today announced new steps to target harmful products marketed as dietary supplements, including the […] Read More >>
Then he slid down the chimney. A rather tight pinch, but if Santa could do it, then so could the Grinch. He thought to himself, I must address this […] Read More >>
By: Ashleigh Hampton, MSc December 5, 2011 Previous reports of resveratrol have suggested that resveratrol undergoes extensive metabolism, thus resulting in a low bioavailability of the parent compound (As reviewed […] Read More >>
Clara di Tella, BSc, Pharm. QA Regulatory Affairs Specialist, dicentra Inc. On November 24, 2011 the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations […] Read More >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc. Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of […] Read More >>
Manushvi Chadha, BPharm, RA Cert Regulatory Affairs Associate, dicentra Inc. Nanomaterials are engineered molecules whose defining characteristic is their size – they range from 1-100 nanometers where each nano is […] Read More >>
Clara di Tella, BSc, Pharm QA Regulatory Affairs Specialist, Dicentra The United States Food and Drug Administration along with regulatory agencies from 80 other countries have completed the International Internet […] Read More >>
Ashleigh Hampton, MSc Scientific and Regulatory Affairs Associate, Dicentra There have been some challenges faced while assessing the therapeutic effects of resveratrol in humans. Phase 1 clinical trials have reported […] Read More >>
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