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 >>
Health Canada defines Natural Health Products (NHPs) as “naturally occurring substance that are used for the number of reasons such as the prevention or treatment of an illness or condition, […] Read More >>
On November 5, 2018, the Federal Register revealed new guidance on Nutrition and Supplement Facts Labels with questions and answers related to the Compliance Date, Added Sugars, and Declaration of […] Read More >>
In July of this year, the FDA announced new innovative approaches that demonstrate safety and efficacy for nonprescription drug products while expanding consumer access to more products. These innovative approaches […] 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 >>
In May 2018, the Bill S-5 received Royal Assent for Canada’s new Tobacco and Vaping Products Legislation (TVPA). With this update, all vaping products that are not subject to the Food […] Read More >>
Prop 65, California’s right-to-know law that requires a clear and reasonable warning for chemicals known to cause cancer or reproductive harm, finds that coffee does not require a cancer warning. […] Read More >>
On February 14th, 2018, the NNHPD held a one-day technical session in Ottawa seeking input from the Health Products Associations’ members about updates to the Natural Health Products’ Management of […] Read More >>
Proposition 65, and what you need to know for your products Proposition 65, Prop 65 for short, is the Californian law requiring companies to warn consumers if they may be […] Read More >>
During the 1990s there were a series of high profile global food safety crises. From a regulatory point there was a lack of direction, a lack of oversight and a […] Read More >>
STAY ALERT AND AWARE OF PENDING CHANGES THAT MAY IMPACT YOUR BUSINESS How does the Food Safety Modernization Act affect your business? What do the latest guidance documents say? What are […] Read More >>
Overcoming Regulatory Hurdles with Foods & Health Products: Bringing New Products, Ingredients and Technologies to the Canadian Market How do we differentiate ourselves in a marketplace saturated with me-too products? […] Read More >>
Thursday, January 16, 2014 Three Part Webinar Series Provided by dicentra and Knowledge Bank Foods vs. Dietary Supplements: Cross Dressing Products Dear dicentra Subscriber, Jut in time for our upcoming […] 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 >>
GMP Training Makes Good Business Sense If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, lack of proper […] 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 >>
http://www.crnusa.org June 2, 2011 CRN Submits Comments Concerning Regulatory Cooperation Between the U.S. and the E.U. That Would Help Eliminate or Reduce Unnecessary Divergences in Regulation and in Standards Used […] Read More >>
http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm June 22, 2011 The U.S. Food and Drug Administration (FDA) is notifying the public about the possible presence of a plasticizer called diethylhexyl-phthalate (DEHP) in certain food and beverages Read More >>
http://www.naturalproductsinsider.com/ NPF Notifies FTC, FDA of Non-Compliant Ads WASHINGTON –The Natural Products Foundation (NPF) alerted FTC and FDA of 13 non-compliant advertisers that have failed to amend marketing materials after […] 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 >>
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