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 >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, Dicentra From late September to mid October the NHPD will be holding information sessions in Montreal, Toronto, Vancouver, and Halifax […] Read More >>
Manushvi Chadha, BPharm, RA Cert Regulatory Associate, Dicentra The FDA recognizes that the production of FDA-regulated products has gone international, with more globalization on the way. Not only wholly manufactured […] Read More >>
Novel Food Approval: EU Approves Rooster Comb Extract (RCE) Rupika Malhotra, MSc Regulatory Associate, Dicentra In recent years, several novel and arguably eccentric food ingredients have made their way into […] Read More >>
Health Canada Update: Non-Medicinal Ingredient Labeling for Nonprescription Drug Products Clara di Tella, BSc, Pharm QA Regulatory Affairs Specialist Health Canada has released a notice to inform drug manufacturers/sponsors of […] Read More >>
After a long cold winter it’s with extreme excitement that we welcome the spring and the coming summer. Spring always brings with it a feeling of renewal and enthusiasm for […] Read More >>
Welcome Spring and Summer 2011 After a long cold winter it’s with extreme excitement that we welcome the spring and the coming summer. Spring always brings with it a feeling […] Read More >>
The Debate Surrounding the Sale of Unapproved Natural Health Products Continues Despite Health Canada adopting a risk-based enforcement policy until at least March 31 in acknowledgment of the Product License […] Read More >>
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