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FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

by Jenn Porter | 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...
Phase I of the Self-Care Framework

Phase I of the Self-Care Framework

by Jenn Porter | 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...
Changes to INCI Names for Hydrocarbons

Changes to INCI Names for Hydrocarbons

by Jenn Porter | 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...
Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching

Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching

by Jenn Porter | 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...
Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2)

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2)

by Jenn Porter | 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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    Delsie Braganza

    Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all submissions made to Health Canada and the US FDA.

    Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

     

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    Robert Fichtner

    Since co-founding Focal Point over 20 years ago, Rob has led our Regulatory and Scientific practice. A chemist by training, his experience includes Cosmetics, Drugs, Medical Devices, Consumer Products and Natural Health Products (Dietary Supplements). Rob has participated in the launch of thousands of products including their formulation, manufacturing and regulatory submissions for approval. His wealth of experience spans almost 40 years in innovation.
    Rob has been involved in all aspects of innovation and new product development. He shares some of his insights in his new video series “Lectures in Innovation”. You can view the first video here.
    When not supporting innovators, Rob spends his time becoming a better sailor and guitar player.