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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.
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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
Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act, 2021″. Included within this omnibus legislation are several provisions that affect…
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
A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say following a sale, for…
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
The FDA annouced a proposal to ban vape (e-cigarette) flavored products including mint and menthol. The details are just emerging but here’s what’s been released…
Out of Date Drug Listings
FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…
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…
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 90-days of…