Hardware Podcasts

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

Let's Combinate · 13 Jan 2025 · 7m

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains why pre-filled syringes (PFS) are classified as combination products and how regulatory requirements vary by region. He details the US FDA's Primary Mode of Action (PMOA) framework, the EU's MDR Article 117 requirements, and the drug-led approaches in China and Japan. Saadeh uses a case study of filling water for reconstitution to illustrate the technical and regulatory hurdles, emphasizing that understanding jurisdiction-specific definitions is critical for product design and approval timelines.

Most relevant to

early-stage companies

Topics

Mentioned

Also
FDA, CDER, CBER, MDR, GSPR, EMA, ASTM Committee E55, Combination Products Coalition

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