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What is the federal ‘CDER’ in terms of pharmaceutical liability?


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This blog has previously mentioned the fact that the federal agency that is responsible for ensuring the safety and efficacy of various medications and drugs is the Food and Drug Administration. Now, like most large governmental organizations that are charged with protecting the public, the FDA is divided into numerous departments or sections. When it comes to the regulation of pharmaceuticals in the United States, perhaps the most important of these departments is the Center for Drug Evaluation and Research.

Though the name of this particular part of the FDA may make it sound like a government research lab to Texas residents, that’s not necessarily the case. While one component of the CDER does do some limited testing, the main purpose of the center is to evaluate the research that has been done by the drug manufacturers and submitted to them for approval. It is thus the responsibility of the various pharmaceutical corporations to do the research and testing necessary to show that the proposed medication is both safe and effective.

When a company seeks to place a new drug into the stream of commerce, it generally files a new drug application with the CDER. Then, the Center will have a group of science professionals from various fields review the evidence presented by the company to determine if the medication is, in fact, ready to be produced, marketed and sold to the general public. It is important to note that the CDER relies on the drug manufacturer for accurate information about the research and testing that has gone into the proposed pharmaceutical.

While most of the time, this collaboration between the private sector and the government regulators works to protect the safety of consumers, there are times when it fails. Whether it is due to an unscrupulous company falsifying research to get a drug approved, or an honest mistake in the design and research of the medication, the results can be devastating to the victims of unsafe or ineffective medicines. Experienced Texas attorneys may be able to give guidance in collecting damages in cases of pharmaceutical liability.

Post Type: Topical

Anchor Text: Pharmaceutical Liability

Keywords: drug manufacturer

Primary Target URL: /Pharmaceutical-Injury/

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