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08

Oct 2020

Sample Distribution in Canada under the CUSMA Agreement – What to Know
Sample Distribution in Canada under the CUSMA Agreement – What to Know
By
In Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to […] Read More >>

06

Aug 2020

FDA – OTC Monograph Reform under the CARES Act – What to Know?
FDA – OTC Monograph Reform under the CARES Act – What to Know?
By
In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by […] Read More >>
Happy Holidays from dicentra Inc.
December 14, 2011 By
  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 >>
Stability Guidelines for Natural Health Products on the Horizon
November 21, 2011 By
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 >>
Health Canada Releases Policy Statement on Nanomaterials
November 14, 2011 By
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 >>
FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet
October 3, 2011 By
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 >>
NHPD Seeks Industry Feedback on A New Risk Based Approach to Site Licensing
September 19, 2011 By
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 >>
Novel Food Approval: EU Approves Rooster Comb Extract (RCE)
August 22, 2011 By
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 >>
Non-Medicinal Ingredient Labeling for Nonprescription Drug Products
August 8, 2011 By
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 >>

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