A majority of us have come across a product with the sign “FDA Approved” or on a company’s website and even on commercials announcing new treatments and products. Many more marketers sell us their products/services stating that they’re FDA Approved.
The big Q however, is; how can you as the consumer be sure the product/service is FDA approved? First, we need to know what FDA is; The Food and Drug Administration is the United States federal agency charged with overseeing Health and Human Services.
The FDA regulates human and animal drugs, food and animal feed, cellular, vaccines and gene therapies (biologics) and products which emit radiation.
Unfortunately, not all FDA drugs pass under the aggressive premarket approval stage. Safety and effectiveness review conducted by FDA experts before the product gets the approval to be distributed into the market.
Below we look at instances where FDA approved after the investigation stage:
FDA Approved Drugs
New biologics and drugs need to be ascertained as safe and effective by the FDA before companies marketing them are given the go-ahead to market them.
Companies manufacturing said products share their test/subject findings with experts working for the FDA review laboratory, animal, and human clinical trials.
When the Food and Drug Administration agency approves a product, it means that the benefits outweigh the risks.
Contrary to popular belief; the FDA Agency doesn’t have the prerogative to approve drug manufacturers, laboratories or health care facilities. However, the FDA is mandated with inspecting product manufacturers to ascertain that they are complying with the set manufacturing practices.
FDA Doesn’t Approve Compounded Drugs
Pharmacy compounding involves the mixing or altering of ingredients in drugs to create medications that are unique to the needs of particular individuals. Compounding is an old practice that falls under the FDA’s scrutiny.
Pharmacy compounding has proven to be effective for many patients with unique cases such as allergic reactions to FDA-approved drugs. However, consumers are warned that compounded medications are not regulated/approved by the FDA.
So; poor compounding practices are rampant since these medicines are not passed through the safety and effectiveness stages of the FDA. Patients are asked to be careful about said drugs and always consult widely before consumption.
Risked-Based and Tiered Medical Devices Regulating Approach
All devices passing through the Food and Administration Agency is classified according to risk. High-risk devices including; implantable infusion pumps and mechanical heart valves are subjected to FDA approval before they are introduced into the market.
Manufacturers wanting to get approval for said devices are required to produce evidence that the devices are safe and efficient.
When it comes to drugs, always go for FDA Drugs (FDA Approved Drugs). These are drugs that have been tested and proven to work before being released in the market.
Always make sure that you confirm through the FDA website that a drug has been approved for consumption to avoid any risks.