Massachusetts Dangerous Drug Attorney

How Does a Drug Get Approval for Use?

New drugs are going through the review process and arriving on the consumer market all the time, according to information from Drugs.com, which states that annually, spending on the manufacture and approval of pharmaceutical medications totals nearly $13 billion. Pharmaceutical companies that are developing a drug must put that medication through clinical trials with no less than several thousand patients, a process which takes several years to complete.

Prior to the clinical trials, however, the pharmaceutical medication must go through a number of additional rigorous tests and processes in order to receive approval. These rules and regulations are monitored by the U.S. Food and Drug Administration (FDA), the federal agency which governs the use and distribution of prescription drugs. Prescription drugs, unlike over-the-counter drugs, fall into a category of their own, which subjects them to strict compliance standards and thorough testing in order to be released for prescribing. While the FDA does evaluate new and proposed pharmaceutical drugs, the manufacturer themselves are responsible for the testing and trials that each drug must go through.