Correction to: Patient Registries: An Underused Resource for Medicines Evaluation

Operational proposals for increasing the use of patient registries in regulatory assessments

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Correction to: Drug Safety https://doi.org/10.1007/s40264-019-00848-9

The fourth sentence under the heading “1.1 Use of Patient Registries for Supporting Regulatory Assessments” in “1 Introduction” section should read as below:

For certain products, registry studies may provide post-authorisation data to fulfil regulator-imposed obligations to confirm safety and/or effectiveness, as is the case with the recently authorised chimeric antigen receptor (CAR) T-cell products, tisagenlecleucel and axicabtagene ciloleucel [8, 9].

In addition, reference 5 should read as below:

5. European Medicines Agency. Patient Registries. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries. Accessed 25 Aug 2019.

The citation of reference “[6]” should read as “[5]” in Sects. 3, 4 and 6.

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Correspondence to Patricia McGettigan.

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McGettigan, P., Alonso Olmo, C., Plueschke, K. et al. Correction to: Patient Registries: An Underused Resource for Medicines Evaluation. Drug Saf 42, 1353 (2019). https://doi.org/10.1007/s40264-019-00859-6

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