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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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Out of Date Drug Listings
FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…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…
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?”…
Redacting a FOIA Request
Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…
FDA Approved Meaning
FDA Approved Meaning One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there…
FDA Due Dilligence Review
FDA Due Diligence Review Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic…
FDA Shutdown
FDA Shutdown The partial government shutdown, now in its 24th day with impacts at the FDA felt across all its Centers. Currently, with the FDA shutdown,…
Microneedling 510(k)
Microneedling 510(k) The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The…