Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

This.

I think people don't really understand the requirements you need to meet to get and maintain FDA clearance. I think even under the current administration, you still could have an obligation to do that testing.



That’s all true when the medicine is made here. More and more of every day medicine these days is made in countries with fewer safety regulations like India and China. FDA may inspect them from to time but they have no jurisdiction to actually do anything about violations.


FDA does have jurisdiction. They may prevent imports from manufacturers who violate FDA regs.

Where it is made does not change the rules.

https://www.fda.gov/industry/import-program/actions-enforcem...


But, how is strong is the enforcement regime for labs outside the US?


They can stop the product being sold in the USA, which is usually a big deal.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: