FDA Faults Cytogam Sales Literature For Unsubstantiated Long-Term Survival Claim
This article was originally published in The Pink Sheet Daily
Clinical trial's long-term survival was not statistically significant, agency says in letter to CLS Behring.
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EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.