DCCA CBER Meaning and
Definition
-
DCCA CBER stands for Drug Control and Certification Branch of the Center for Biologics Evaluation and Research.
The Drug Control and Certification Branch (DCCA) is a division within the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). CBER is responsible for regulating and evaluating biological products, including vaccines, blood and blood products, gene therapies, and certain medical devices. The DCCA specifically focuses on the control and certification of drugs used in biological products.
The DCCA CBER plays a crucial role in ensuring the safety, quality, and effectiveness of drugs used in biologics. They are responsible for evaluating drug substance and drug product manufacturers to ensure compliance with regulatory standards and Good Manufacturing Practices (GMP). This involves evaluating drug manufacturing facilities, reviewing manufacturing processes, and conducting inspections to assess product quality and consistency.
The certification aspect of DCCA CBER involves the issuance of Certificates of Free Sale and Certificates of Exportability for biologics drugs. These certificates serve as proof that a specific product meets the necessary regulatory requirements and can be safely distributed domestically or exported internationally.
Overall, DCCA CBER contributes to the regulatory oversight and control of drugs used in biological products, aimed at protecting public health and ensuring that biologic drugs meet the necessary quality and safety standards.
Common Misspellings for DCCA CBER
- scca cber
- xcca cber
- ccca cber
- fcca cber
- rcca cber
- ecca cber
- dxca cber
- dvca cber
- dfca cber
- ddca cber
- dcxa cber
- dcva cber
- dcfa cber
- dcda cber
- dccz cber
- dccs cber
- dccw cber
- dccq cber
- dcca xber
- dcca vber
Infographic
Add the infographic to your website:
