FDA Q&A
Out of Date Drug Listings
FDA to deactivate out-of-date drug listings in its database The US Food and Drug Administration (FDA) has announced that it will deactivate out of date…
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 Due Dilligence Review
Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic company, you need to…
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, most if…
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…
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…
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…
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…