Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
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CBER Rare Disease Program
Description of CBER’s Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.
Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER
Use of Artificial Intelligence and Machine Learning (AI/ML) has rapidly become an important component of everyday life. This includes using AI/ML in the development of Medical Products, including Biologics. This page provides an overview of CBER’s activity in AI/ML.
CBER Biologics Effectiveness and Safety (BEST) System
This is the main page for CBER’s Biologics Effectiveness and Safety (BEST) System.
Industry (Biologics)
CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.