If the FDA identifies a violation of the law it is entrusted to enforce, the agency may take action in the interest of public safety. One way the agency protects consumers from unsafe drugs and medical devices post-approval is through an FDA recall. Drug companies and device manufacturers often go along with FDA recalls voluntarily. In some cases, however, they … Read More
The FDA Approval Process
The road toward Food and Drug Administration (FDA) approval begins long before the agency actually gets involved. The pharmaceutical company starts with its own laboratory research and animal trials. Later, it takes the first formal step in the FDA’s pharmaceutical approval process by submitting an investigational new drug (IND) application. The medical device approval process follows a similar path. The … Read More
About the FDA
What is the FDA? The Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services. The FDA has broad regulatory authority over not just food and drugs, but also biologics such as vaccines, medical devices, tobacco products, certain cosmetics, and some veterinary products. The agency was formed in 1906 and today employs … Read More