BioPharm International-09-15-2019

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Regulatory agencies and pharmacopeia organizations revised policies and guidelines in 2019.

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.