Latest Medical Device User Fee Amendment (2022) FDA has released the new medical device user fee amendment (MDUFA) for 2022. The US Food and Drugs Administration has established a 2.5% increase in Fees charged to Medical Devices manufacturers. This fee increase includes applications for Premarket Approval, 510(k) clearance, establishment registration and other applications in […]
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Pre-consultation Notice on the Proposal to Amend the Cosmetic Regulations Health Canada calls for the attention of interested parties towards the proposal to amend the Cosmetic Regulations. The goal of this regulatory initiative is to achieve more transparency about the presence of specific allergens in cosmetic labels. The notice specifies that the proposal
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US FDA OTC Monograph User Fee for FY 2021 Update The US Food and Drug Administration (FDA) announced new Over-the-Counter (OTC) Monograph consumer fees for fiscal year (FY) 2021 on March 26, 2021. The OTC Monograph User Fee Program (OMUFA), which was created by the passage of the March 2020 CARES Act, would require
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FDA Provides Extension for Unique Facility Identifier (UFI) Deadline of Food Facilities The US Food and Drug Administration (FDA) announced in 2016 that food facilities would be required to have a Unique Facility Identifier (UFI) as part of their FDA registration as part of an update to Food Facility Registration processes. D-U-N-S® numbers are currently
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CBD FDA Labeling Requirements Remains a Grey Area Filled with Concerns The U.S. Food and Drug Administration (FDA) has increased its scrutiny of CBD labeling and marketing practices. Hemp-based product uses are increasing, and many investors and consumers are unaware of the grey areas of the industry. Stakeholders in the industry have pushed for
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Cosmetics Responsible Person – Who is it?  Whether you’re EU manufacturers, Non-EU manufacturers, importers or distributors, it’s important to understand who is the Cosmetics Responsible Person (RP), what they do, and what is the benefit of appointing a RP.  Especially If you are a non-EU cosmetic company, You should consider assigning a professional Cosmetics Responsible
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FDA Withdraw The New OTC Monograph User Fee for FY 2021 January 5, 2021 Update: FDA decided to withdraw their newly published OMUFA fees on December 29, 2020 Federal Register Notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021″ till further notice. In the past March, President Trump
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FDA Cosmetic Approval: What You Need to Know About The FDA regulates drugs and cosmetics, but when a cosmetic is considered a drug, it can become difficult for manufacturers to discern whether their product is classified as an FDA OTC drug or a cosmetic and if requires FDA cosmetic approval. FDA OTC Drug product regulation
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FDA Food Facility Registration Renewal: October 1 to December 31, 2020 FDA registration renewal is due between October 1 and December 31, 2020 for all food facilities. The renewal is required for any facilities that engage in the following US food for consumption activities: • Manufacturing • Packing • Processing • Storing Renewing the FDA
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UK Cosmetic Regulations: What You Need to Know On January 31, 2020, the United Kingdom and the European Union signed a cosmetic regulation. The changes will not have an impact on UK cosmetic regulations initially due to a transition period. The period lasts for one year and, can be extended for an additional year as
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