Data integrity is increasingly an area of focus during regulatory inspections across the GXP world and has been the subject of several guidance documents from the FDA, MHRA, and PIC/S. Review of inspectional observations suggests the industry is still struggling to...
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Preparing for Your FDA Inspection
At some point on your journey to an approved drug, biologic, or medical device, you (and any contract organizations you’ve hired to help you with nonclinical, GLP, and clinical studies as well as manufacturing) will be subject to inspection by the regulatory...
Background Research for Your IND/NDA/BLA/Market Application
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...
Where Did Former FDA Commissioner Scott Gottlieb Go?
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...
Drug and Biologic Labeling for Drug Abuse & Dependence Potential
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...
War Games as a Strategy Tool
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...
How Are Citizen Petitions Used?
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...
Your Options When Disagreeing with a CDRH Action or Decision
It may seem as if a negative decision on your device application is final; however, that is far from the truth. CDRH has multiple processes for resolving disputes with any external stakeholders (sponsor, industry, or public) which are included in the applicable...