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FDA Exemption to E-Cigarette Deeming Rule
***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed,…
FDA Picamilon Status
In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter on the same…
Criminal Charges USPlabs LLC
Breaking News – Criminal Charges USPlabs LLC The US Department of Justice and the Food and Drug Administration announced criminal charges and other civil charges. The…
FDA Holiday Imports
The time is fast approaching where US shoppers will begin their holiday shopping. FDA holiday imports are a common feature of the holiday season in…
New FDA Automatic Destruction Rule
Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015). The rule is titled, “Administrative…
FDA Criminal Liability – PCA and the DOJ Yates’ Memo
Peanut Corporation of America executives Stewart Parnell and Michael Parnell were sentenced yesterday following a conviction last year for their role in the salmonella outbreak linked…
FDA Shutdown – Preparing for the Likely Government Shutdown
***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could…
FDA Warning for Kim Kardashian
A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog….
Regulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings…
FDA Microneedling Regulations Status Update
Befuddled and Confused – Microneedling and the FDA One of the most common questions received in our office is whether a product is “FDA Approved.”…
510k Exempt Medical Device Guidance
510k Exempt Medical Device Guidance New Guidance Expands Class I and II Exemption to Devices Previously “Unclassified” or “Reserved” New 510 Exempt medical device Guidance…
Understanding FDA Accession Numbers for Electronic and Radiological Devices
Understanding FDA Accession Numbers for Electronic and Radiological Devices Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product…