(905) 271 2709 mail@focalpointresearch.net
Focal Point
  • Home
  • About
  • Team
  • Services
    • Cosmetic Consultants
    • Natural Health Products
    • Drugs
    • Medical Devices
    • Consumer Products
    • Technology
    • FDA Consulting
    • Health Canada Consultants
    • Regulatory Affairs
    • Pharmacovigilance Services
  • Innovation
  • Articles
  • Contact
Select Page
FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

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...
Health Canada: Mandatory Use of New Regulatory Enrolment Process for Drug Submissions

Health Canada: Mandatory Use of New Regulatory Enrolment Process for Drug Submissions

by Emily C | May 12, 2020 | Canadian Regulatory, OTC Drugs, Research/Science/Technology, U.S. Regulatory, Uncategorized

Recently, Health Canada announced that the Regulatory Enrolment Process (REP) will be mandatory to use as of October 1, 2020. The Health Products and Food Branch (HPFB) will be implementing this single window for transmission of regulatory transactions in electronic...

Recyclable Cosmetic Packaging – A Step Closer to an Eco-Friendly World

by Jennifer P | Mar 19, 2019 | Cosmetics, Research/Science/Technology

As environmental awareness increases, consumers are looking for products that are sustainable for a better future. This means buying cosmetics and personal care products that are packaged in materials that are not going to end up in landfills or contribute to...

Expanded Sunscreen Pilot – Health Canada

by Jennifer P | Mar 14, 2019 | Canadian Regulatory, Cosmetics, OTC Drugs, U.S. Regulatory

Having fun in the sun is usually not a good idea without having proper sunscreen protection. Sunscreens are equipped with active ingredients that prevent damage from UV rays by using either chemical or physical UV filters. However, with most sunscreen products in...

Alexa – Your New Best Friend for Cardiovascular Health?

by Jennifer P | Mar 5, 2019 | Medical Devices, Research/Science/Technology

For patients facing the ongoing health concern of having high blood-pressure, it can be difficult to monitor the status of their condition over a long period of time. It may be a feasible option to check blood-pressure on a daily basis, and take medication to control...
« Older Entries

Recent Posts

  • FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021
  • Phase I of the Self-Care Framework
  • Changes to INCI Names for Hydrocarbons
  • Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching
  • Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2)

Recent Comments

    Archives

    • March 2021
    • February 2021
    • January 2021
    • November 2020
    • October 2020
    • August 2020
    • July 2020
    • June 2020
    • May 2020
    • April 2020
    • March 2020
    • February 2020
    • January 2020
    • December 2019
    • November 2019
    • October 2019
    • September 2019
    • August 2019
    • July 2019
    • May 2019
    • April 2019
    • March 2019
    • February 2019
    • January 2019
    • December 2018
    • November 2018
    • October 2018
    • September 2018
    • August 2018
    • July 2018
    • June 2018
    • May 2018
    • April 2018
    • March 2018
    • February 2018
    • January 2018

    Categories

    • Canadian Quality Assurance
    • Canadian Regulatory
    • Cosmetics
    • European Regulatory
    • Events/Company Updates
    • Importation of NHPs
    • Innovation
    • Innovation
    • Medical Devices
    • Natural Health Products
    • OTC Drugs
    • Our View
    • Research/Science/Technology
    • U.S. Regulatory
    • Uncategorized

    Meta

    • Log in
    • Entries feed
    • Comments feed
    • WordPress.org
    Copyright © 2021 Focal Point Research Inc.
    Privacy Policy | Terms of Use
    Website Design and Development by PLAY