The Process of Getting New Drugs Approved in the United States

For the last 20 years, Robert Gadimian, has worked in the drug development and regulation sector, helping pharmaceutical companies get their products approved. In the United States, pharmaceutical companies must have their products approved by the FDA, and Robert Gadimian is extremely experienced with FDA guidelines.

The process for FDA approval involves five stages. The stages are as follows: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring.

The first thing a pharmaceutical company does is conduct laboratory tests. Then, the drug is carefully tested on – first on animals and then on human subjects. Afterward, FDA scientists review the research and guidelines the pharmaceutical company has compiled on how the drug will be used. The FDA’s goal is to determine whether the drug’s risks are higher than its potential benefits. They also verify that the drug can be manufactured in a way that ensures quality and safety. When the pharmaceutical company fulfills these conditions, the FDA allows the drug to be manufactured and marketed in the United States.

After production, the FDA continues to monitor the drug to make sure it does not cause health hazards.

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How Cystic Fibrosis Can Be Treated

President of the Burbank, California firm Perceptive-Regulatory Consulting the Robert Gadimian is an authority in pharmaceutical research. Also the leader of Rophe Pharma, presently, Robert Gadimian is working on a patent related to novel compounds that treat cystic fibrosis.

Cystic fibrosis is a hereditary illness that does not have a cure. However, there are ways to at least manage symptoms. Primarily, the disease affects the exocrine glands, causing the production of extremely thick mucus and leading to the blockage of some of the respiratory organs. Hence, one way to treat cystic fibrosis is to take medication to improve the function of these organs. These medications include antibiotics to tackle the respiratory infections that the disease may cause.

Another treatment approach is cystic fibrosis is pulmonary rehabilitation. This involves exercise, breathing techniques, nutritional advice, counseling, and education. Pulmonary rehabilitation is used to treat people with chronic respiratory diseases, and cystic fibrosis is no exception. Physical activity helps to clear the “frozen” mucus in the lungs, resulting in better breathing and, generally, better health.

Finally, there a few surgical procedures that can help in treating cystic fibrosis. They include nasal and sinus surgery, bowel surgery, lung transplant, and liver transplant.

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