The Food & Drug Administration (FDA) is tasked with ensuring the safety and efficacy of medical products sold in the United States. In addition to medications and medical devices, the FDA has jurisdiction over veterinary drugs, food, biological products, cosmetics and radiation emitting devices. Among other things, the agency must review all prescription drugs and medical devices before they can be legally sold in this country. The FDA also monitors medical products after they have been cleared for sale in order to identify unexpected complications that could put consumers at risk for serious adverse events.
The FDA approval process for prescription medications is regulated by the agency’s Center for Drug Evaluation and Research (CDER). In order to obtain clearance to sell a new medication, drug companies must first conduct pre-clinical animal studies to prove safety and efficacy. If those studies are successful, the manufacturer can submit an Investigational New Drug (IND) application to the CDER in order to move on to human clinical trials. Such trials are divided into three distinct phases:
Once all three Phases are successfully completed, the drug maker will submit a New Drug Application (NDA) to the FDA. The CDER expects to act on most standard NDA’s within 10 months. However, the goal for priority drugs is six months. In certain approvals, the FDA may require a manufacturer to conduct a Phase IV post-marketing study to address potential concerns over a drug’s safety, effectiveness or cost.
The FDA’s Center for Devices and Radiological Health (CDRH) is charged with regulating all medical devices sold in the U.S. For the purposes of approval, medical devices are assigned to one of three categories:
Class III medical devices are subjected to the FDA’s most stringent approval process. Before such a product can come to market, a device manufacturer must provide ample clinical evidence that it is both safe and effective.
In certain instances, the FDA may allow a device to undergo its 510(K) clearance process, which does not require any pre-clinical testing at all. A device is eligible for this process if a manufacturer can show that it is substantially equivalent in design to a product that had previously been approved by the FDA. However, the 510(k) system is controversial, as critics claim certain devices cleared in this manner – including transvaginal mesh and metal-on-metal hip implants – have caused significant harm to thousands of patients. If you have been affected you may be able to file a case.
Unfortunately, the FDA’s system for clearing new drugs or medical device for sale does not always identify all of the risks associated with a product. For that reason, the FDA continues to monitor the performance of medications and medical devices during their lifetime on the market. Among other things, the agency maintains the MedWatch program, which allows healthcare professionals, consumers, and patients to report adverse events they may have observed or experienced in relation to medical products regulated by the FDA, including drugs and devices. If any troubling trends are identified via the MedWatch program, the FDA has the power to issue safety alerts or order product recalls, withdrawals, or labeling changes in order to protect public health. Please continue to visit Injury Beacon for the latest news.
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