EMA Reports on Withdrawal of Court Cases on Clinical-Trial Data

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-04-2014 10:31


The European Medicines Agency (EMA) confirms that AbbVie has withdrawn both its court cases brought against the agency concerning access to clinical-trial data.

In particular, following the successful appeal against the interim rulings issued against the agency in April 2013, the EMA was requested to consider an entirely new set of redacted documents and related justification for redaction proposed by the company. The very limited redactions proposed by AbbVie were consistent with the agency’s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.

Another court case brought by InterMune against the agency challenging a decision to grant access to clinical-study reports is still ongoing.

Source: EMA


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