FDA Q&A
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
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,…
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…
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…
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….
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…
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…
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…
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 The Draft Guidance document is available here.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…
Medical Device User Fee Rates for Fiscal Year 2018
Medical Device User Fee Rates for Fiscal Year 2018 The US FDA announced Medical Device User Fee Rates for Fiscal Year 2018 on Monday morning (August 28,…