Fresh Frozen Plasma (FFP) powder for reconstitution or liquid

Form: liquid units or lyophilized (freeze-dried) powder

Strength: available in 200-250 mL units

Reference Brands: No specific brands

Category: Plasma Products

Frozen Plasma (FFP), used for coagulation correction and volume resuscitation, is regulated in the US by the FDA and in the EU via EMA approval pathways. Regulatory approval requires a comprehensive dossier including manufacturing standards, donor screening, safety, efficacy, and pharmacovigilance plans. In the US, FDA review assesses clinical and quality data, while EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of FFP products worldwide, supporting optimal patient care in critical bleeding and coagulation disorders.