News and Updates
Stay Ahead of the Curve - Join Our E-mail List for the Latest FDA/USDA Updates!
Upcoming Events in Charlotte and Washington D.C.

Microneedling Classification Order

Microneedling Classification Order The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was issued in response to a De Novo application submitted by Bellus Medical. The Microneedling Classification Order follows a microneedling guidance issued on Sept. 14, 2018. The Draft Guidance document is available here.

Continue Reading →

Government Shutdown

Government Shutdown A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and here). Although unpredictable and difficult to plan around on short-notice it is important to be aware of the impact this could have. One that affects both industry and consumers. In the

Continue Reading →

FDA Warning Letters 2017

FDA Warning Letters 2017 FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along with a summary of Inspectional Observations from the previous fiscal year. As an FDA attorney, it is important for my firm to understand enforcement trends to help clients respond to

Continue Reading →

FDA Bitcoin

FDA Bitcoin FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether Bitcoin or blockchain technologies are FDA approved. The first question bound to bubble-up at some point – does the FDA accept Bitcoin? The short answer is, no. The FDA does

Continue Reading →

CDER Direct

CDER Direct   CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings. It is intended as an improvement on the Electronic Submissions Gateway (ESG) portal that relies on a SPL X-form editor. The integration of the SPL-X editor into the system is

Continue Reading →

FDARA Marketing Status Report

FDARA Marketing Status Report FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed into law. FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug

Continue Reading →

FDA Homeopathic Drugs

FDA Homeopathic Drugs FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject of a Compliance Policy Guide (CPG), which is an explanatoryatory note for FDA staff and industry.  As CPG Sec. 400.400 explains, the FDA recognizes and permits homeopathic drugs recognized by

Continue Reading →

FDA Cosmetic Safety and Modernization Act (S2003)

FDA Cosmetic Safety and Modernization Act (S2003) Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill, like many of its predecessors, including Personal Care Products Safety Act (S.1113) and Cosmetic Modernization Amendments of 2017 bill (H.R. 575), would fundamentally change the cosmetic industry.  Senator Hatch’s FDA Cosmetic Safety

Continue Reading →

FDA Microneedling Guidance

FDA Microneedling Guidance FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here and here. Only a summary of the microneedling guidance posted today. Below is the constituent update announcing the release. As expected it appears the FDA will propose a

Continue Reading →

← Previous Page