FDA News Update

Synthetic Nicotine Loophole Getting Shut Down By The Congress

Congress will close the synthetic nicotine loophole this week when it passes an omnibus spending bill. What Is in the Current Bill? Subtitle B of…

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Why was created the Remote Regulatory Assessments (RRA)?

Remote Regulatory Assessments A Remote Regulatory Assessment is a necessity created by the COVID-19 pandemic. Ordinarily, FDA would conduct an on-site audit as part of…

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Is the Premarket Tobacco Product Applications (PMTAs) stagnated?

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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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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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Out of Date Drug Listings

FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…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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510(k) Process

510(k) Process There are many questions about the 510(k) process, but none is more common than, “how long does it take?” The stock answer of…

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Plasma Microneedling

Plasma microneedling is a new medical device raising a number of questions. The most common question received is, “is it FDA cleared or FDA approved?”…

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