Regulatory Focus™ > News Articles > Perspective: Issues with Proposed Regulatory Pathways for Follow-on Biologics

Perspective: Issues with Proposed Regulatory Pathways for Follow-on Biologics

Posted 01 August 2011

Most small molecule drugs are produced through some chemical synthesis steps and purified through a rigorous process. This enables production of substantially pure active pharmaceutical ingredient (API), which is characterized further by various physical and chemical methods.

 

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