Quality aspects of phage therapy medicinal products
Quality aspects of phage therapy medicinal products
Quality aspects of phage therapy medicinal products
Opinions and letters of support on the qualification of novel methodologies for medicine development
Annex IV - Discussion meeting with applicant - molecule-independent device bridging approach (MIDBA)
Annex I - Briefing document - molecule-independent device bridging approach (MIDBA)
Annex III - Written responses to list of issues - molecule-independent device bridging approach (MIDBA)
Annex II - Initial Qualification Opinion List of Issues - molecule-independent device bridging approach (MIDBA)
Draft qualification opinion for molecule-independent device bridging approach (MIDBA)
Draft guideline on quality aspects of phage therapy medicinal products
PSUSA/00010468/202501
PSUSA/00009084/202412