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 … 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. … Read more