Tracking Drug Manufacturing Plant Inspection Reports Online

Health Canada has put all Drug Establishment License (DEL) holders on alert as to their regulatory responsibilities and obligations for maintaining good manufacturing practices (GMP).  In addition to increasing the frequency of planned and unplanned inspections of...

US, Canada, and EU – Who wins the Drug Approval Race?

Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data.  A new study, funded by the Pew Charitable Trusts (to be published in...