Untitled Letter Sent to Fidia Pharma

CBER’s Office of Compliance and Biologics Quality has issued an untitled letter to Fidia Pharma USA after reviewing the company’s Web sites and determining that its cell/tissue products require a BLA or NDA. The product, NuDYN, is derived from amniotic membrane and marketed for treating various orthopedic diseases and conditions, the letter says.

It asserts that the product requires an approved BLA due to claims the company is making. For example, the letter cites the following claim to support its regulatory decision: “Potential specialty applications” include “orthopedics...sports medicine...pain management...and podiatry.” It also takes issue with a patient guide that states: “Your doctor will decide the best way to use this product for your specific condition.”

CBER requests that the company respond within 30 days and address the regulatory issues raised in the letter.