Key Senator Hinges Support For Cheap Drug Imports On Surprise Inspections
More unannounced inspections abroad would warm Senate Finance Committee chairman to President Trump's drug importation plan.
You may also be interested in...
Plan envisions manufacturers, acting under FDA guidance, will import their own drugs and introduce them in the US under a new national drug code at a lower list price.
As FDA and other regulatory authorities throughout the world learn how to conduct the type of inspections that have put a spotlight on data integrity failures in India, they are warning that no manufacturer, no matter how sophisticated they are, no matter where they’re located, is immune from this potentially devastating issue.
A sharp increase in data integrity findings has raised questions about the quality of pharmaceutical manufacturing in India. What’s happening and why, who’s responsible, and how can drug makers and the regulatory agencies that watch over them put a stop to it?