Ombudsman pushes EMA for explanation of Humira CSR redactions

The EU ombudsman has asked the EMA to explain redactions to clinical study reports (CSRs) for AbbVie's ($ABBV) Humira. The EMA responded quickly to the publication of the letter, issuing a release to outline its approach to the redaction of commercial confidential information. The regulator is working on a detailed response to the ombudsman's letter, which asked why the EMA made 16 sets of redactions. Letter | More

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