The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for recognizing voluntary consensus standards (VCS) related to pharmaceutical quality with an aim to promote innovation in pharmaceutical development and manufacturing.
This program applies to the gamut of CDER-regulated products, including brand drugs, generics, biologics, biosimilars and over-the-counter (OTC) medicines. FDA added that the program “will help create efficiencies in generic and biosimilar manufacturing which is an important part of streamlining generic and biosimilar development and spurring competition as part of our Drug Competition Action Plan (DCAP) and Biosimilars Action Plan.”
The guidance describes CDER’s plans to publish a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality and describes CDER’s policies and procedures for recognizing such standards…
