Question

Identify two articles from the published literature that make recommendations about the U.S. Food & Drug Approval process. In your own words, provide feedback on their recommendations.

Answer 1

ANS) The FDA center for Drug Evaluation and Research (CDER) is working as a guard for possible medications requesting approval for using in the United States of America. In this case if the CDER want to start valuing a drug , the pharmaceutical firms should first have to do complete testing and record the conclusions about that particular drug.

And after that this conclusions are directly sent to the CDER, who allocate a group of chemists, pharmacologists and some scientists in different fields to evaluate the proof.From first formulating to FDA acceptance ,almost all type of drugs takes atleast 10 years of time to bring that drug into the market.By this we will understand this is a big process but at last what happens is that ,only the safe drugs make it to the pharmacy.

Moreover we can say that this FDA will make the medical items most effective,safe and also most affordable,and also helps to get the correct information about every medical products.

The Drug development Method requires a variety of steps..,

1) Finding and Development- Here the scientists will try to find new options of medication by experimenting the molecular compounds ,and also saving effects of that medication from the existing analysis.And the development process occurs after understanding the possible compounds for the testing by the scientists.

2) Preclinical experimentation- This is to text the toxicity level of the drug.This can be in two types- Invitro or Invivo

3) Clinical Experimentation- In this step the scientists will check how this drug will making dealing in the human body.That means in this step the scientists will try this in human body.This is the most important step in the drug approval process.

4) The next one is the FDA Evaluation- Now after the positive testing of a drug from the company, the company can give an application to the FDA for marketing approval of that drug.

5) The last step is the FDA post market welfare observation- The scientists are needed to work for many years to know the welfare possibility of a particular drug, but still there will be many problems,but that problems will arise only after the publishing of drug in the market place.

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