Once again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”). The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments. The seven issues include:
- “HDA urges greater appreciation for and recognition of the ‘distributed model’…”
- “HDA recommends topics to address at the February 28 public meeting”
- “We expand upon certain data standard and exchange issues from the December public meeting”
- “…we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
- “We summarize our understanding of the aggregation and inference discussion at the public meeting…”
- “HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA”
- “…various other issues raised during the public meeting…”
Continue reading HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS
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