Newsletter - October 29, 2015
Are Indian Drug Manufacturers Really That Bad in GMP Compliance?
In recent years, any event of an FDA Warning Letter or other actions towards drug manufacturers located in India is headline news for most media sources. Warning Letters to Indian manufacturers are projected as evidence of an industry wide culture of non-compliance and there seems to be a strong perception that Indian drug manufacturer may be the worst GMP offenders in the entire industry. However, a careful review of FDA’s audit findings paints a different picture. Read More..
Compounding Expensive FDA-Approved Drugs to Reduce Price: Potential Challenge to the 505(b)(2) or Generic Pathway
If your prescription drug is too expensive, can you simply buy a compounded drug to get a cheaper version? And if this goes forward, does it not create a challenge for all developers of 505(b)(2) or even generic drugs? What about expanding this logic to the very expensive biological drugs? Would FDA allow that? The news could have very disturbing undertones. The excessive price hike for a life-saving drug, Daraprim, by Turing Pharma recently brought the drug price debate....Read More..
Research Productivity: Who Discovers More, Academia or Industry?
Time and again it has been debated if the public funding into academic research is justified in terms of the “return on investment”, namely, does academia generates enough products for public good compared to the R&D labs in industry. In a recent opinion piece in Wall St Journal, it was suggested that scientific innovation is not driven by academic research but by technological evolution in our knowledge over time. Read More..
Are Indian Drug Manufacturers Really That Bad in GMP Compliance?
In recent years, any event of an FDA Warning Letter or other actions towards drug manufacturers located in India is headline news for most media sources. Warning Letters to Indian manufacturers are projected as evidence of an industry wide culture of non-compliance and there seems to be a strong perception that Indian drug manufacturer may be the worst GMP offenders in the entire industry. However, a careful review of FDA’s audit findings paints a different picture. Read More..
Compounding Expensive FDA-Approved Drugs to Reduce Price: Potential Challenge to the 505(b)(2) or Generic Pathway
If your prescription drug is too expensive, can you simply buy a compounded drug to get a cheaper version? And if this goes forward, does it not create a challenge for all developers of 505(b)(2) or even generic drugs? What about expanding this logic to the very expensive biological drugs? Would FDA allow that? The news could have very disturbing undertones. The excessive price hike for a life-saving drug, Daraprim, by Turing Pharma recently brought the drug price debate....Read More..
Research Productivity: Who Discovers More, Academia or Industry?
Time and again it has been debated if the public funding into academic research is justified in terms of the “return on investment”, namely, does academia generates enough products for public good compared to the R&D labs in industry. In a recent opinion piece in Wall St Journal, it was suggested that scientific innovation is not driven by academic research but by technological evolution in our knowledge over time. Read More..
