Specific comments on text Line Comment and rationale; Recommendation number(s) proposed changes (To be completed of the (If changes to the by the Agency) relevant wording are suggested, text they should be (e.g. highlighted using 'track Lines changes') The title refers only to Amend title to refer 6-8 and antibacterial agents, but either to all 3 17-18 lines 130-131 indicate that classes of agents by the document could apply name or to to antimycobacterial and “antimicrobial antifungal agents as well. agents” as an overall entity. 130 Most of the Add systemically “… recommendations made in administered” to the guideline do not apply trial sentence to non-absorbed and locally or topically acting agents. 187-188 It is suggested that this sentence may be better placed under “Scope” (Section 2)
Specific comments on text Line number(s) of the relevant text (e.g. Lines Comment and rationale; proposed changes (If changes to the wording are suggested, they should be highlighted using 'track changes') Recommendation (To be completed by the Agency) 6-8 and 17-18 The title refers only to antibacterial agents, but lines 130-131 indicate that the document could apply to antimycobacterial and antifungal agents as well. Amend title to refer either to all 3 classes of agents by name or to “antimicrobial agents” as an overall entity. 130 Most of the recommendations made in the guideline do not apply to non-absorbed and locally or topically acting agents. Add “… systemically administered” to sentence 187-188 It is suggested that this sentence may be better placed under “Scope” (Section 2) trial
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx