The Role of the US FDA Agent for Cosmetics, OTC and Drug Products If you’re a foreign manufacturer of Cosmetics and OTC medications and prescription drug products, appointing a US Agent for FDA purposes is crucial. But what exactly does a US FDA agent do? First of all check here the difference between a […]
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How to get a DUNS number for food facility registration with the FDA In the United States, both domestic and foreign facilities engaged in the manufacturing, processing, packing, or storage of food intended for human or animal consumption are required by law to register with the U.S. Food and Drug Administration (FDA). This registration process
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US FDA OTC Monograph User Fee for FY 2022 The US Food and Drug Administration (FDA) announced new Over-the-Counter (OTC) Monograph consumer fees for fiscal year (FY) 2022. The OTC Monograph User Fee Program (OMUFA), which was created by the passage of the March 2020 CARES Act, would require covered OTC drug facilities to
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Over the counter drug registration in the US An OTC drug or over-the-counter drug is a product that has generally been considered safe to use without a doctor’s prescription. Many people in the United States need drugs to treat certain ailments and at times when the condition being treated doesn’t necessarily require a visit to
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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 covered
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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
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FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment This article has been updated on the 5th of January 2021 https://cosmereg.com/fda-withdraw-the-new-otc-monograph-user-fee-for-fy-2021/ In the past March, President Trump had signed a pandemic aid act named “CARES”. This act featured a measure that reshapes and upgrades the manner specific OTC and non-prescription drugs are
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What is the active ingredient in all FDA approved hand sanitizers? FDA issued a final rule on April 11 regarding ban certain dangerous active ingredients in OTC hand sanitizer products. After reviewing the safety and effectiveness of hand sanitizers, the normative concluded a previous determination from FDA that, 28 active ingredients, including triclosan and benzethonium chloride, are
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New FDA Sunscreen Regulations in the near future: What you need to know? Sunscreen products are classified as over-the-counter OTC products. FDA just released a new proposal of FDA sunscreen regulations. The proposed law requires products to be safe and effective. This update means that all non-approved sunscreen products currently sold in the
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SIs It Mandatory FDA Establishment Registration? Overview of When FDA Establishment Registration is Required FDA establishment registration varies depending on the FDA regulated product marketed and sold. Various types of FDA facility registration are discussed in the sections below. In general, prior to entering the market a company must classify the product, determine if FDA approval
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