About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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    • 100 Menlo Park, Suite 550
      Edison New Jersey 08837 -2488

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Sollers Blog

How Long Does It Take For The FDA to Review a NDA?

Posted by Doctor Dan on Sep 15, 2016 10:50:07 AM

The process of creation of a drug to getting it in a market place is a lengthy process. Every process, right from the pre clinical trials to the FDA approval is scrutinized and meticulously tested for any risks and potential health hazards. Each drug is developed to cure a specific disease. The tests are conducted to ensure that the formulations of these drugs meet the regulatory standards and also solve the purpose of curing the disease. Even after the drugs hits the market, they still go through continuous testing for any side effects. Many drugs and their additional use have been discovered in this process.

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The evaluation process for any drug that gets approved by FDA is rigorous. Right from the design to the severity of its side effects, every aspect of the drug is tested before they are manufactured in bulk quantity. Even sponsors and research institutions can develop new drugs. All of them must go through the detailed and long term evaluation process. This goes to say that, a drug that is developed in a scientific laboratory does not escape evaluation by FDA.

Clinical research on drugs is conducted by research as well as non research scientists. The metabolism of the drug and how this drug is excreted is tested in the first phase. It is tested on healthy individuals who volunteer this testing. When the first phase does not show toxicity, it reaches the second phase of testing. It is tested for its effectiveness to cure the disease it is designed to cure. Once there is an evidence of its positive effect, the FDA approves the drug, and meeting is conducted with the sponsors for large scale production. Data for marketing of the drug is gathered before marketing the drug.

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Topics: Drug Safety