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An advisory committee recommended them for the 503A Bulks List by an 86 vote against FDA staff advice
However, current evidence seems to suggest a link between the two
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Adverse event terminology standardization was achieved through implementation of the Medical Dictionary for Regulatory Activities (MedDRA), which employs a five-tier hierarchical classification system: System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT)
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