The Food and Drug Administration (FDA) is a division of the United States Department of Health and Human Services. The agency works with other federal agencies and with private companies to ensure that drugs are safe and effective, food is safe to eat, and medical devices are both safe and effective. The FDA also investigates outbreaks of illness caused by food, water, medicine, or any other product that can be harmful if used incorrectly.
In addition to working with many other government agencies, the FDA has several programs through which it cooperates with industry. These include:
• The FDA review process. Before a drug can be sold in the United States, it must be shown to be safe for its intended use by submitting an application to the FDA. If a company wants to make changes to their original formula, they must submit another application. Once approved, a drug can only be changed or removed from the market if the manufacturer files suit claiming that the old formula is no longer equivalent to the new one. In such cases, the FDA will usually grant a license for the older formulation while the lawsuit is being resolved.
• Special studies. The FDA may ask manufacturers to conduct studies on their products.
The Food and Drug Administration (FDA) oversees medical devices, including clinical trial equipment. The agency also has authority over drugs but typically doesn't review studies until after they have been completed. Drugs are classified as new drugs or generic versions of already-on-the-market drugs.
However, it is important to note that not all clinical trials are subject to regulation by the FDA. Only certain types of studies qualify as "new drugs" and thus require investigation by the agency before they can be sold in the United States. These studies include: initial investigations of drugs intended for oral administration; new drug applications for medications that are modified or derived from existing drugs; and large scale, long term studies of drugs used for treating chronic illnesses. Studies involving vaccines or other therapies that are not drugs under federal law do not need FDA approval. However, sponsors must comply with any general ethical guidelines set out by the Office of Human Research Protection (OHRP) within the Department of Health and Human Services.
Industry groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and patient organizations such as U.S. Patients Act Now!
The Food and Drug Administration (FDA), a regulatory body of the Department of Health and Human Services, is in charge of ensuring the safety and efficacy of medications supplied in the United States. The FDA separates this duty into two stages. It begins with the inspection of facilities where drugs are made or processed before they are sold to verify that they meet federal standards. If problems are found, the facility can be closed down until they can be fixed. Once on the market, drugs must be shown to be safe and effective through rigorous testing procedures. The agency conducts these trials itself and works with other government agencies and private organizations to identify potential risks associated with drugs during their review process.
All pharmaceutical products are required to be proven safe before they can be sold. In addition, drugs cannot be marketed unless they show evidence of being more effective than existing alternatives. Drugs cannot simply make claims about their effectiveness without supporting data; instead, they must be tested against known controls to determine if they are better than what is already on the market.
The FDA does not review whether you need medication or not. They check only to make sure that no harmful substances are present in drugs or that they are as effective as they claim to be. Therefore, it is important that you only take a drug that has been proven to be safe for its use and that you do not substitute another product that may have different properties.
The FDA is a federal organization under the United States Department of Health and Human Services that serves as the principal regulatory authority for food and drug substances in the United States. As part of its mission, the FDA requires that all drugs and other substances be proven safe before they can be sold or used in the United States. The FDA also regulates medical devices such as needles, syringes, and knives to prevent their abuse by children or others who could be injured by them.
In addition to regulating pharmaceutical products, the FDA monitors the manufacturing process to ensure that drugs are not contaminated with particles or chemicals that could be harmful when taken by humans. The agency also ensures that medications are safe by reviewing the data from clinical studies that new drugs must undergo before they can be marketed. If the FDA finds problems with the study design, results, or conclusions of a study, it may request changes to the research project or refuse to approve the drug until it is satisfied with the changes made.
Although the FDA does not regulate foods, it does review dietary supplements to make sure they are safe and do what they claim to do. Like drugs, supplements cannot be sold if they contain ingredients not listed on the product label or if they have been altered in any way during manufacturing.