Katrina’s Blog™

When doing your background work in preparation for a new or updated submission, it can be helpful to understand the structure, personnel and process in the FDA offices with whom you may be working. There are a number of ways you can gather this information, including...

Regular readers will recall my post in March about the departure of FDA Commissioner Scott Gottlieb. He returned to his previous company, venture capital firm New Enterprise Associates Inc, as a Special Partner on their healthcare investment team. He’s also now a...

The regulations for the content and format of labeling for human prescription drug and biological products (found in 21 CFR 201.57(c)(10)) provide for a special section to convey information on a drug’s potential for abuse, misuse, addiction, physical dependence, and...

I just read an article in Life Science Leader about the use of war games as a strategy tool. This is not a new concept; rather, it’s just a differently structured and more formal way to think more deeply in a strategic mode with a group of up to 40 participants. For...

In my last post, I reviewed the new guidance on the processes available to resolve disagreements arising from official actions or decisions made by members of CDRH. One of those processes is citizen petitions, and because I was interested in how these were used, I...