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Drug Manufacturing: FDA Approval Process

There are millions of people taking pharmaceutical drugs for a variety of health reasons. Patients are dependent upon these drugs for their life’s sustenance, and when they purchase these prescribed drugs, they expect to receive the health benefits they’re paying for. Drug manufacturing companies are responsible for making sure drugs are safe for use before they submit them to the Food and Drug Administration, and a failure to do so could cause serious health defects or even cost a consumer his or life.

U.S. Food and Drug Administration

Drugged Driving AccidentThe U.S. Food and Drug Administration (FDA) is responsible for monitoring drug manufacturing companies’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. These regulations consist of minimum requirements for the methods, facilities, processing, and packaging of drug products and require that all drugs are safe for consumption. Furthermore, they must contain the ingredients and strength printed on the labels.

Phases for Approval for New Drugs

There are five phases that new drugs must pass to be approved by the FDA and sold to consumers. The first phase is discovery and development. Researchers discover new treatment methods by testing molecular compounds, and they then produce more once they’ve selected the appropriate compounds. The second phase is preclinical research. When researchers have an idea of the new drug’s potential abilities, they do a preliminary analysis to determine if the drug is potentially harmful. This process allows scientists to determine if the new drug is safe for human intake. The third phase is clinical research. Trials are conducted on people using the drug, which helps scientists analyze and discover if the new drug can cure certain ailments. Phase four is an FDA review. After researchers prove that the new drug is safe for human consumption and can provide treatment,  they apply to allow marketing for the drug. Researchers must submit clinical results, safety information, drug abuse potential, and directions for use. The FDA then reviews the data, taking up to ten months to decide if they’ll approve the new drug. The FDA will consider the application as well as the clinical site that orchestrated the research. The final phase is FDA post-market safety monitoring. Despite researchers spending months determining the safety of a drug, issues can still arise after the drug is on the market. Because of this, the last phase of drug approval is ongoing and exists in perpetuity.

Because drug approval is time-consuming, it’s expected that by the time drugs reach the market they’re completely safe for use. However, that’s not always the case. Some drugs slip past the FDA and have hazardous and life-threatening consequences on consumers. Having an experienced attorney to help assist with dangerous drug tort is imperative in order to receive compensation for any injuries.

At Los Angeles Injury Group, we have attorneys who are experienced with drug tort claims and can help you receive compensation for medical expenses, emotional distress, and loss of wages. If you, or someone you love, has received injuries from dangerous pharmaceutical drugs, call 888-954-7248 to receive a free consultation.

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    Note for the readers: This post has been derived from the use of secondary sources and the information provided has not been independently confirmed. The photos depicted in these posts are not representative of the actual accident.  Any inaccuracies will be swiftly corrected once they have been brought to the site’s attention and all requests to remove posts will be honored.

    Disclaimer: This post is intended to provide general information to our readers and to honor the victims of everyday tragedies. We do not wish to cause any disrespect and none of the information contained in this post should be construed to constitute legal or medical advice. Laws vary by jurisdiction and cases often turn on minor differences In fact. Do not rely exclusively on any of the information contained in this post and seek further assistance from a legal or medical professional, where necessary.

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