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How Does the FDA Drug Approval Process Work?

Americans are privileged to have access to the safest — not to mention most advanced — pharmaceutical program in the world. From Provo, Utah to the East Coast, The U.S. Food and Drug Administration (FDA) is the primary authority on drug safety, and is responsible for not only evaluating new drugs, but for providing information about drugs to patients and doctors.

The process of gaining FDA approval for a new drug on the market is substantially involved and tedious; however, the process is necessary to ensure that Americans stay safe — especially as new drugs are engineered each and every year. Even if a drug is FDA-approved, sometimes recalls still occur — resulting in the need for a drug injury lawyer.

The Role of the CDER

Companies who want to sell their drug within the United States are required to go through a rigorous testing period. After this initial testing period — assuming the results are acceptable — the company must send the evidence to the Center for Drug Evaluation and Research (CDER). Physicians, chemists, pharmacologists, scientists and statisticians working with CDER thoroughly review the data and proposed corresponding labeling. If the benefits are greater than the risks, the drug will be approved for sale. However, it’s not uncommon for the FDA to issue drug recalls immediately following the approval of a drug, resulting in the need for a drug injury lawyer in areas such as Provo and the Midwest.

Drug Recalls Can Affect Anybody

Contrary to popular belief, the FDA doesn’t test drugs itself; however, it does contribute to research regarding areas of study such as drug quality, safety and effectiveness. The primary purpose of the CDER is to ensure that drugs on the American market are not only effective, but also safe. Many drug recalls in the past (Fen-Phen, anyone?) have resulted in substantial injury — and sometimes even wrongful death — and a call to a drug injury lawyer. It doesn’t matter if the drug was widely distributed in Provo or along the East Coast; the detrimental effects are the same.

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