Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Posted by on July 1, 2020

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare
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Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

Posted by on June 25, 2020

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Not surprisingly, investors highly scrutinize these proceedings and stock markets react accordingly. For these reasons, it is critical for
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NDA vs. OTC Monograph: Which Pathway is Right for You?

Posted by on June 22, 2020

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market.
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4 Problems Importing Rapid Antibody Tests for Coronavirus

Posted by on June 19, 2020

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. However, applying for a COVID-19 EUA Letter from FDA is
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Will FDA Authorize Your Product Health Claims?

Posted by on June 15, 2020

According to FDA regulation, conventional food and dietary supplements are allowed to make three categories of claims: health claims, nutrient content claims, and structure/function claims. The FDA tightly regulates the use of these types of claims, with significant penalties for manufacturers who do not comply fully and properly. Nonetheless, many manufacturers, either out of misunderstanding
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OTC Monograph User Fees are Cancelled for FY2020

Posted by on June 11, 2020

Surprising news emerged from the FDA early this week – OTC Monograph User Fee program (OMUFA) facility fees for fiscal year 2020 have been dropped.
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Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

Posted by on June 8, 2020

On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic. These steps included revising the temporary guidances to clarify manufacturing and compounding certain alcohol-based hand sanitizer products. The revised guidances are listed and linked
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FDA requirements for coronavirus tests with at-home specimen collection

Posted by on June 4, 2020

Although FDA continues to streamline its process to submit a package requesting an Emergency Use Authorization (EUA) letter for SARS-CoV-2 diagnostic tests, it can be challenging and the precise nature of the submission must be followed.
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FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs

Posted by on June 2, 2020

In a recent webinar hosted by the FDA, Dr. Theresa M. Michele, director of the Office of Nonprescription Drugs at CDER, revealed a significant update on the generally recognized as safe and effective (GRASE) status of hundreds of Monograph ingredients.
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How to apply for an FDA Coronavirus Emergency Use Authorization Letter

Posted by on May 27, 2020

Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process.
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