The FDA approved drugs are nothing but the medications and the medical appliances that are approved by the authorities. The FDA is referred as US Food and Drug Administration. They are the ones who are responsible for examining, testing and approving a wide range of things that are for medical usage.
They would see whether the benefits would outweigh the risks or not and only after that they would go about approving it. They would also look at the color that is mixed in the drugs and much more.
How does FDA approve a medication?
Before a medication goes onto sale at a pharmacy, the US Food and Drug Administration follows a three-tier screening process to approve a medication. They would first divide the drugs into three categories namely high risk, moderate risk, and lower risk.
If the pill or the medical device falls into the first category then they would have the highest level of evaluation but if it falls under the second category these medications would have a little less evaluation. The third category is nothing but lower risk medications and devices and these are often over the counter drugs or items like a bandage.
Who would check the authenticity of the medication?
The FDA would not test it; instead, the drug manufacturing company should provide the clinical test results of the medication. However, they would have their own chemists, physicians and statisticians to examine the results that are provided by the company.
Apart from this, the manufacturer of the pills has to be present before the Food and Drug Administration agents during these and should answer their questions. If the Food and Drug Administration believes that the medication can provide help to the patients and if they feel that the medicine manufacturer has followed all the standards then they would approve a medication.
What to check for in FDA approved drugs?
If you come to know that a medication is Food and Drug Administration approved then you have to get the answer to the question and that is to what medical ailment that the authorities have authorized this drug for.
For example, if you take Viagra and Cialis, it is permitted for treating both erectile dysfunction and pulmonary arterial hypertension. It means it is safe to use this medicine for these medical ailments.
You would have heard a term called as off-label. Viagra is taken for off label purposes to treat jet lag. This is nothing but using the drug for the purpose that is not permitted for. Many health care professionals are known to prescribe the pills to the conditions for which it is not intended for.
Is it a good idea to take FDA approved drugs for some other purpose?
No, you are not supposed to treat your medical ailment with the pills that are not validated for the purpose. By reading the blog, you can know that the Food and Drug Administration does stringent research with the drug before approving it.
Each benefit and risk associated with the medication are examined in this phase. They would come to know about the side effects, the appropriate dosage strength and the action of the pill on the body. So knowing all information regarding a pill before buying it is absolutely vital for patient safety. Healthprose.org provides complete information on a wide range of prescription as well as OTC medications for the patient’s knowledge.
It is not a good idea to take a medicine to treat a condition with no study, research or clinical trials. It is not possible to say if it is safe for the person or not.
Is there any exception to take FDA approved drugs for off-label purpose?
Yes, there is an exception to take FDA approved drugs to treat off-label purpose. For some medical ailments, there would not be any drugs at all and in this case, a doctor would find the best pick from the validated medications and suggest it to the patients.