what laws or what steps must be taken by an inventor of new medicine before being released into the market?

Question

am working on a paper on the law and its relevane in science and technology .i would like someone to enlighten me with the steps that a company for example glaxo must take before releasing the medicine to the market.i know there must be some testing for side effects and publication but that about it.which law exactly covers this/

Answer 1

My mom works for at a diabetes and glandular research clinic. Part of their research involves groups of voluntary test patients who live at the facility while taking the new meds (usually being tested by one of the big companies like Pfizer ot Mercke (sp?)...the patients' reactions (or lack of reactions) are carefully monitored by the research doctors and nurses. The studies can last anywhere from a few days to a few weeks... the patients are usually paid a compensation of some sort for volunteering their bodies for research.

If the drug proves successful, I think it has to go through a couple more stages before hitting the market... or being dropped from it.

Answer 2

Look up stuff from the FDA. They regulate all of those kinds of things.