This concerns labeling for ingredients present unintentionally as a consequence of cross-contact or cross-contamination at any point along the food chain (during raw material transportation, storage or handling, due to shared equipment for processing and packaging, etc.). Experts in this field propose that if allergen labeling is to be useful to consumers, and healthcare professionals who advise and treat those consumers, ideally there should be agreement on which foods require labeling, threshold quantities below which labeling may be of no purpose, and validation of allergen detection methods to test and potentially recall foods that were deliberately or inadvertently contaminated.Labeling regulations have been modified to provide for mandatory labeling of ingredients plus voluntary labeling, termed precautionary allergen labeling (PAL), also known as "may contain" statements, for possible, inadvertent, trace amount, cross-contamination during production. PAL labeling can be confusing to consumers, especially as there can be many variations on the wording of the warning. PAL is optional in the United States. As of 2014, PAL is regulated only in Switzerland, Japan, Argentina, and South Africa. Argentina decided to prohibit precautionary allergen labeling since 2010 and instead puts the onus on the manufacturer to control the manufacturing process and label only those allergenic ingredients known to be in the products. South Africa does not permit the use of PAL, except when manufacturers demonstrate the potential presence of allergen due to cross-contamination through a documented risk assessment and despite adherence to Good Manufacturing Practice.
Elapegademase, sold under the brand name Revcovi, is a medication for the treatment of the rare disease adenosine deaminase deficiency-SCID in children and adults.It is a recombinant enzyme that is administered weekly by intramuscular injection.Elapegademase may interact with PEGylated drugs.Elapegademase-lvlr was approved by the U.S. Food and Drug Administration (FDA) in 2018. Leadiant Biosciences was awarded a priority review voucher for its development under the pediatric rare diseases program. References
External links
"Elapegademase". Drug Information Portal. U.S. National Library of Medicine.