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Fda Transitioned Insulin To Biological Products

In this final guidance document, FDA provides Sponsors with answers to commonly asked questions regarding the BPCIA. The move is expected to have no impact on the distribution of insulin and other products affected by the transition. Section 351(k) defines “biosimilarity” to mean that the biological product is highly similar to the reference product notwithstanding […]

Two cycles on the stand

Interdum et malesuada fames ac ante ipsum primis in faucibus. Morbi tristique mauris nec arcu rutrum, vel egestas sapien fermentum. Vestibulum a dui in nunc sollicitudin imperdiet. Integer lacinia ac neque nec cursus. Phasellus semper a nibh vel malesuada. Maecenas ut libero ultrices lacus sodales porttitor. Suspendisse a quam in risus molestie iaculis non nec […]

Focusing on work on a Sunday morning

Interdum et malesuada fames ac ante ipsum primis in faucibus. Morbi tristique mauris nec arcu rutrum, vel egestas sapien fermentum. Vestibulum a dui in nunc sollicitudin imperdiet. Integer lacinia ac neque nec cursus. Phasellus semper a nibh vel malesuada. Maecenas ut libero ultrices lacus sodales porttitor. Suspendisse a quam in risus molestie iaculis non nec […]

Taking time to make colorful art

Interdum et malesuada fames ac ante ipsum primis in faucibus. Morbi tristique mauris nec arcu rutrum, vel egestas sapien fermentum. Vestibulum a dui in nunc sollicitudin imperdiet. Integer lacinia ac neque nec cursus. Phasellus semper a nibh vel malesuada. Maecenas ut libero ultrices lacus sodales porttitor. Suspendisse a quam in risus molestie iaculis non nec […]

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