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Use new, sterile equipment for each injection and make a visual check of: the condition and cleanliness of the product, the label (date, active substance, strength) and the contents (whether there are fragments of broken glass or plastic, discolouration, precipitates or other abnormalities)

We solicited public comments about whether including ASP data from the reference product in a variant of the proposed calculation would produce a more appropriate payment limit for a biosimilar with only negative or zero manufacturer's ASP data

While animal studies suggest significant potential for tendon-to-bone healing, human clinical trials are currently limited