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How The FDA Approves New Medications

With so many new medications hitting the market each year, the Food and Drug Administration (FDA) has developed an extensive application process to protect consumers by ensuring that only safe and effective medications are available for purchase or for prescribing by a physician. The FDA’s Center for Drug Evaluation and Research (CDER) is in charge of evaluating and approving new medications via a multistep application process.

Step One: Laboratory Testing

Before a medication is ever reviewed by CDER, it undergoes extensive laboratory testing that usually lasts around three to four years. The testing at this stage often involves animal trials, and if these are successful, the company manufacturing the medication submits an Investigational New Drug (IND) application. The IND application must show that the medication is reasonably safe for human trials and that its pharmacological activity justifies commercial development. If these conditions are met, CDER approves the medication for clinical trials.

Step Two: Clinical Trials

Clinical trials are broken into three phases to efficiently test several different qualities of any new medication. Phase one will establish a drug’s safety on a small number of volunteers. Phase two will measure effectiveness on several hundred patients. Phase three involves several thousand patients from different clinics and hospitals. The medication’s effectiveness is again analyzed and patients are monitored carefully for any adverse effects.

Step Three: CDER Approval

After completion of the clinical trials, the pharmaceutical manufacturer submits all of its testing data to CDER in a New Drug Application (NDA). Not only will CDER review the clinical trials, it will also analyze manufacturing specifications, stability data, dosage forms, and packaging and labeling. This process typically takes several years. If CDER determines that the benefits of the medication outweigh the risks they approve the medication

While the FDA’s approval process involves a review of new medications, the harmful effects of some pharmaceuticals are uncovered long after they have been on the market. If you suffered side effects due to your ingestion of a defective drug, you need an experienced products liability lawyer to help you get the compensation you deserve from the pharmaceutical company. Contact Blizzard Law PLLC for a free case review.


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