Blog

Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

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Do you have a Case That Requires FDA or USDA legislation?

Running a business requires a lot of specialized skills. For one, financial management is crucial. Being able to effectively manage your finances is non-negotiable! Marketing,…

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Are PMTAs Frozen?

Over the past few weeks, I continue to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no. The…

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Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act,…

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PMTA Tips

PMTA Tips There are a few tips in preparing a Pre-Market Tobacco Application (PMTA). Since the September 9, 2020, PMTA deadline for e-cigarettes (also known…

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FDA IHCTOA Letter

What does IHCTOA mean? FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert something may…

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Microneedling FDA Clearance

Microneedling FDA Clearance Microneedling FDA Clearance has been granted to Esthetic Education LLC for its SkinStylus SteriLock MicroSystem (K200044). Esthetic Education is among the very…

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510(k) Transfer of Ownership

510(k) Transfer of Ownership A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say…

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Coronavirus EUA Submission

Coronavirus EUA Submission– Importing N95 Masks and Hand Sanitizers As the novel COVID-19 Coronavirus continues to spread our office has been flooded with Coronavirus EUA…

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FDA Flavor Ban

The FDA flavor ban was announced today through a new Guidance document (link here). It is important to emphasize that this is not a new…

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FDA Vape Ban

FDA Vape Ban The FDA annouced a proposal to ban vape (e-cigarette) flavored products including mint and menthol. The details are just emerging but here’s…

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Out of Date Drug Listings

FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…

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FDA Embargo

FDA Embargo FDA embargos typically refer to state embargos since this is not an enforcement tool used by FDA or allowed under the Food Drug…

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