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  1. Safety & Availability (Biologics)

CBER-Regulated Products: Possible Causes of Shortages

Patient Access to CBER-Regulated Products

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), knows that it is important to patients and healthcare professionals to have access to the CBER-regulated products they need, when they need them.

CBER works with all stakeholders on strategies to prevent and mitigate shortages of these products. CBER's Office of Compliance and Biologics Quality (OCBQ) directs the CBER-regulated product shortage program.

When do Shortages of CBER-Regulated Products Occur?

A CBER-regulated product is considered medically necessary when it is used to treat, cure, mitigate, prevent, or diagnose a serious or life-threatening disease or medical condition and there is no other available source or alternative therapy.

A CBER-regulated product shortage occurs when a product that is regulated by CBER is not commercially available in sufficient quantity to meet the demand.  For example, a product shortage can occur when the total available supply of a licensed, approved, or cleared product will not meet the current demand and there is no adequate alternative therapy available that is judged by appropriate medical staff to be a suitable alternative.

What are the Most Common Causes of Shortages of CBER-Regulated Products?

Quality problems at the manufacturing facility are the most common causes of CBER-regulated product shortages. Other causes of product shortages include increased demand, corporate delays in manufacturing or shipping, distribution disruptions, production changes, unavailability of component materials, new indications, decisions to discontinue the product, or natural disasters.

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