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Biosimilar biological product

A biological medicine that is highly similar to an existing FDA-approved biological product, with no meaningful clinical differences from the original drug. They are often more affordable alternatives.

Biosimilar biological product establishment

A facility or company involved in making, preparing, or processing biosimilar biological products, which must be registered with the FDA.

Mutual recognition agreements

Agreements between regulatory authorities of different countries that allow them to accept each other's inspection outcomes for manufacturing facilities, avoiding duplicate inspections.

Remote regulatory assessments

Inspections or evaluations conducted by the FDA without physically visiting a facility, often using virtual tools, document reviews, or video conferencing.

Strategic plan

A formal document outlining an organization's goals, objectives, and the actions it will take over a period to achieve them, typically addressing challenges and priorities.