How do you get a drug approved from the fda?
My daughter takes a med that is not fda approved. The cost for a year is 1300. Don't sound like a whole lot but when all the other medical bills keep coming in it is alot.
- Anonymous1 decade agoFavorite Answer
The FDA approval process for a new drug to be marketed is rigorous and long. The average time to market for a new drug is 12 years.
First of all, despite the conspiracy theorist's paranoid opinions, pharmaCEUtical companies don't own the FDA. If they did they'd not have to spend millions of dollars getting the research done to submit it for approval and then the drugs would cost less. The approval process goes something like this:
Pharmaceutical companies identify what are called NCEs or "new chemical entities" that show promise in treating some disease. They will run several tests with laboratory animals to determine which ones are safe and bioavailable.
When a compound has been isolated to be relatively safe for human consumption, the pharmaceutical company will file a NDA or "new drug application" with the FDA. The compound then enters phase one trials where it is determined to be safe and bioavailable in humans.
If the compound makes it through phase I trials, it then enters phase II trials with a slightly larger population size. If the drug makes it past this point it then enters phase III trials. This is where the efficacy is proven over a very large population size with double-blind trials versus placebo. This is the step that actually proves that the drug is effective at treating the disease or condition that the pharmaceutical company claims it will. This is the scientific proof that the medical community uses in its recommendations.
If the drug makes it through phase III trails it is then given a seven-year patent and marketed by the pharmaceutical company. Doctors may write prescriptions for it at this point. There are also phase IV trials conducted by the FDA that monitor the safety profile of a drug post-market.
- mansourLv 43 years ago
LMFAO! Yay, our authorities at artwork adversarial to particular undesirable Cheerios. attempting to regulate each and every thing. i have not study a Cheerios container, yet they don't placed "Statements not licensed by using FDA", or some thing to that result? i comprehend places like GNC placed that on all their products and the products they promote. I see those supplement businesses continually making claims like that. Why unmarried out Cheerios? Down the line, maximum of those FDA licensed drugs finally end up being undesirable on your wellbeing anyhow. i'd p.c.. Cheerios over an FDA licensed drug anyday.
- shiara_bladeLv 61 decade ago
do lots of research and prove it's first safe in animals than while continuing animal research go to 1st stage human trials where it's tested in normal humans to see sideeffects.
2nd stage is when sick people get it in groups of about 30
3rd stage is increased groups to about 300 and can be combined with 4th stage which is where approval is decided.
any drug can be pulled at any time by the company without giving a reason
- joecsekoLv 61 decade ago
Go to the FDA website.There is an online form to fill out to get you on your way.
- How do you think about the answers? You can sign in to vote the answer.
- Anonymous1 decade ago
You have to pay off the pharmasutical companies... they own the fda. Unless you spend millions of dollars and your product doesn't cure anything, you haven't got a chance. Our government is trying to kill us before we can collect social security.
- mandLv 51 decade ago
years and years of studies, trials, tests
- Anonymous1 decade ago
- DesignRLv 51 decade ago
submit all data and research and wait ten years.