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Modernization of Cosmetics Regulation Act of 2022
It appears Congress will pass the first major overhaul of cosmetics regulation in 84 years, giving more authority over the market to the FDA. Congressional…
Synthetic Nicotine Loophole Getting Shut Down By 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…
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…
Is the Premarket Tobacco Product Applications (PMTAs) stagnated?
Over the past few weeks, I have continued to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no….
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,…
Premarket Tobacco Product Applications (PMTAs) Tips
PMTA Tips There are a few tips in preparing a Pre-Market Tobacco Application (PMTA). Since September 9, 2020, the PMTAs deadline for e-cigarettes (also known…
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…
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 first microneedling 510(k)…
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…
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…
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…
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…