FDA’s Inspectional Authority: Inviolate or On Shaky Ground?

I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder  (from his firm's excellent FDALawBlog) surrounding FDA's inspectional authority and whether that authority is "evolving" due to recent Supreme Court decisions. Please... Read more

Smile, You’re On FDA-Camera!

The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more

Welcome To The Party Compounders!

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more

FDA Warning Letters Increase 155% from 2010 Levels

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement activities since 2008.  Alternatively, if you are involved at all with supply chain,... Read more

New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain... Read more