Posts by Marc Sanchez
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, 2021″. Included within this omnibus legislation are several provisions that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Here’s everything you…
Read MorePremarket 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 as Electronic Nicotine Delivery Systems (ENDS)) and e-liquids my firm has filed over 40 PMTAs. Below are a few tips on filing a PMTA, which I recently shared with Avomeen…
Read MoreFDA 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 be wrong. Typically, we talk about FDA Warning Letters, which is a precursor to formal enforcement actions by the Agency. An FDA IHCTOA Letter, however, is a private letter (i.e.,…
Read MoreMicroneedling 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) filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The FDA Atty firm worked with Esthetic Education LLC to file a microneedling 510(k) for…
Read More510(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 following a sale, for example, a particularly important process to follow. The FDA published a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” in December 2014 (See, Docket…
Read MoreCoronavirus 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 submission requests. Many questions are about how to import medical devices and drugs, in particular, and 95 masks and hand sanitizers. It is important to remember that the FDA continues…
Read MoreFDA 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 law. FDA guidance documents are not a source of law but an interpretation of existing law (1). Also, the Guidance Document makesclear that the FDA through this flavor ban is…
Read MoreFDA 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 what’s been released so far. “FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes,…
Read MoreOut 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 drug listings in its database including any that have not been recently updated or are inaccurate, as required by regulation, or that include an establishment with an expired registration. “FDA…
Read MoreFDA 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 and Cosmetic Act (FDC&A). The FDA can issue a seizure or an injunction but both require a court order, which can take time to obtain. Many states, like California, allow…
Read More510(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 90-days of FDA review time tells only half the story. There are many factors that can impact the timing to complete the 510(k) process. Preparing and Pre-Submissions Naturally, before the…
Read MorePlasma 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?” Based on a search of the De Novo, PMA, and 510(k) databases at the time of this post, no entry could be found for plasma microneedling. That means any plasma…
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