Correction to: Patient Registries: An Underused Resource for Medicines Evaluation
- 272 Downloads
1 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 “” should read as “” in Sects. 3, 4 and 6.