Contract Pharma recently published an article addressing some valuable tips to make your trip along the regulatory pathway to report manufacturing changes easier. The author, Amy Schutte, Senior Associate, Regulatory Practice of Lachman Consultants says, “Change is inevitable, continuous, and reportable to the FDA when we are talking about approved human or animal drugs.”
Specifically, this article seeks to discuss some of the challenges caused by changes, and some thoughts on reporting changes, for branded or generic drugs approved for human use under a New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), respectively.
