You can imagine the trepidation of a pharmaceutical company when the US Food & Drug Administration (FDA) comes calling. Given the demanding nature of inspections, recent enforcement actions and the public scrutiny that each warning letter is subjected to, even a battle-ready manufacturing site with the most stouthearted management can't help but feel a ripple … Continue reading Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality
India #Pharma 2014 : A quick look back – Part One #quality
The holiday season approaches, so here's a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It's a mixed bag (what year isn't?) including stuff that could influence the way things work in the years ahead. For convenience, I've divided up what I think are … Continue reading India #Pharma 2014 : A quick look back – Part One #quality
Biosimilars – Indian companies getting real?
So finally the US Food and Drug Administration (FDA) has issued long-awaited draft guidelines for the approval of biosimilars or copycats of biologics that may not be identical to the original but similar enough on safety and efficacy parameters to be switched. See here. This is no humdrum development if you consider that billions of … Continue reading Biosimilars – Indian companies getting real?