Regulatory Affairs

BIO Endorses WHO’s Proposed Name ‘Qualifiers’ for Biosimilars

The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More

Cubist Recalls Another Nine Lots of Cubicin

Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More

Proposal Could Cut Time to Clinical Trials in Brazil

Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. Read More