by Jennifer P | Mar 29, 2021 | OTC Drugs, U.S. Regulatory
In March 2020, provisions were added to the Federal Food, Drug, and Cosmetic Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters...
by Jennifer P | Mar 12, 2021 | Canadian Regulatory, Cosmetics, Natural Health Products, OTC Drugs
Health Canada has announced that there will be updates to the approach to regulating self-care products as part of their 2020-2022 Forward Regulatory Plan. The self-care framework will roll out in phases over the coming years: Phase I – Target Spring 2021 will include...
by Jennifer P | Mar 12, 2021 | Canadian Regulatory, Cosmetics, U.S. Regulatory
The international nomenclature for hydrocarbon ingredients currently designated by INCI names containing the stem terms ‘isoparaffin’ and ‘pareth’ will be revised. ‘Isoalkane’ and ‘alketh’ will replace these terms, respectively, preceded by the appropriate carbon...
by Jennifer P | Mar 7, 2021 | Canadian Regulatory, OTC Drugs
The deadline for the first step of Health Canada’s new risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products is fast approaching. This new Health Canada requirement for all Market...
by Jennifer P | Mar 7, 2021 | Canadian Regulatory, Medical Devices, OTC Drugs
IO No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (IO No. 1) made by the Minister on March 30, 2020 and approved by the Governor in Council (GIC) on April 8, 2020. It...
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