FDA News Update
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
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…
Criminal Charges USPlabs LLC
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…
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
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…
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…
FDA SEC Reporting – Regulatory Reviews for SEC Forms
FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…