Articles

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

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...

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Phase I of the Self-Care Framework

Phase I of the Self-Care Framework

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...

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Changes to INCI Names for Hydrocarbons

Changes to INCI Names for Hydrocarbons

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...

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Extension of Period of Validity for Site Licenses

Extension of Period of Validity for Site Licenses

If you have a Site License set to expire by March 31, 2021, the NNHPD is providing an extension for the site license period of validity until June 01, 2021. This is due to license renewal delays resulting from the COVID-19 pandemic. The extension is applicable to...

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Face Masks – Innovation and Opportunity

Face Masks – Innovation and Opportunity

It is hard to imagine that just one year ago we were shopping and eating in restaurants without fear and without face coverings. Since then, the use of facemasks and face shields has become commonplace even to the point that we feel naked without them when out in...

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The Sunshine Vitamin: What, Where, and How Much?

The Sunshine Vitamin: What, Where, and How Much?

When the majority of people hear the term Vitamin D, they will immediately associate it with images of sunshine, warm climates, and the summer season. That is to say, many people are aware of the essential vitamin and our primary source of obtaining it, but: what...

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A Risk-Based Approach to Site License Applications

A Risk-Based Approach to Site License Applications

In attempt to eliminate the recent issue of site license renewal backlogs, the Natural and Non-Prescription Health Products Directorate (NNHPD) is implementing a new risk based approach to the site license application. With an ambitious goal of removing all backlog by...

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