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Specific Protein Being Targeted by New FDA Labeling Effort


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Specific Protein Being Targeted by New FDA Labeling Effort

Albumin, a term for any protein that is water soluble in concentrated salt solutions, is being targeted by a new Food & Drug Administration labeling initiative.

According to the FDA, there is an extremely remote risk of viral disease being spread through drugs manufactured using albumin. According to in-Pharmatechnologist, the label would read: "Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and vCJD." The condition being referred to is variant Creutzfeldt-Jakob disease.

As the news source notes, the new labels would change how some vaccines and recombinant clotting factor products are packaged. Some vaccines are made with culture media that could contain albumin, and clotting factor products use it later in development as a stabilizing element.

The FDA itself has observed very little chance of epidemiological transmission, but is taking a cautious stance on the matter to avoid any complications.

The FDA frequently takes labeling mandates seriously, and recently even entered a factory that was producing drugs which were falsely advertised.