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License Suspension or Revocation |
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Firms that make biological products (for example, vaccines and blood) are regulated by the FDA's Center for Biologics Evaluation and Research (CBER). Biologics have always been considered different from drugs, and early in the 1900s the U.S. government required that they be licensed. FDA can temporarily suspend or permanently revoke a license if the firm does not comply with cGMPs. For example, here's a Warning Letter which, on the last page, mentions possible “license suspension and/or revocation” along with other actions (that can also be taken against drug products). |
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