Remove 2018 Remove Generic Medicine Remove Labelling
article thumbnail

Drug Repurposing: Unlocking access to rare solutions

Express Pharma

The FDA’s 505(b)(2) pathway and the European Medicines Agency’s (EMA) Hybrid Pathway offer routes for drug developers to rely on previously submitted clinical data, cutting down approval times significantly. As the world’s largest manufacturer of generic medicines, India has vast potential to utilise repurposed drugs.

article thumbnail

World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain

Quality Matters

With this extensive system in place, patients can trust that medicines with the same name will be consistent in quality no matter who manufactures it or where in the world it is made. Since manufacturers know the precise quality specifications, standards help make the approval process for generic medicines more efficient.