14 September 2016
Approaches to clinical trial design and post-authorization monitoring activities for antibacterial medicines were discussed in the meeting. The agencies agreed that requirements for clinical development programs for antibacterial agents should be flexible, specifically where treatment options are limited because of antimicrobial resistance. Meeting participants stated that accepting abbreviated clinical development programs for new antibiotics that address unmet needs may be appropriate.
A summary of the meeting can be found on EMA’s website, and the results of the meeting will be presented at the G7 Health Ministers’ meeting on September 11–12, 2016.
14 March 2024
26 February 2024
NovaMedica team wishes you a Merry Christmas and a Happy New Year!
26 December 2023