Plain English summary People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available tre...

What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to do but hope. Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition. This practice, called “off-label” pre...

Healthcare providers have been rolling up their sleeves along with other adults age 65 and older to get Covid-19 vaccines. Currently, there are three vaccines that authorized for use by the US Food Drug Administration (FDA). This update provides information help healthcare allay some of fears surrounding vaccination answer questions patients asking.

Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot ...

Introduction: There are three synthetic hormones approved by the U.S. Food and Drug Administration (U.S. FDA) for growth promotion in cattle and sheep raised for meat production: the estrogenic compound zeranol, the anabolic steroid trenbolone acetate (TBA), and the progestin melengestrol acetate (MGA). The FDA approves and regulates the use of hormone implants, establishing tolerance levels (m...

A drug called BiDil is poised to become the first pharmaceutical ever approved by the U.S. Food and Drug Administration (FDA) to treat heart failure specifically in African Americans—and only African Americans. On March 8, 2001, NitroMed, then a privately held biotech firm in Massachusetts, issued a press release triumphantly announcing the receipt of a letter from the FDA “describing the regul...

The inhalational drug market, especially the generic market, has a tremendous growth potential globally (GBI Research, 2011; Espicom, 2013; Transperancy: Market Research, 2013). Generics are drugs that are bioequivalent to the approved drugs. The United States Food and Drug Administration (FDA) has defined bioequivalence as (U.S. FDA, 2014), “The absence of a significant difference in the rate ...

This article summarizes the history of the regulation of caffeine, a key component of caffeine-containing energy drinks and other caffeine-containing energy products, in the United States. Caffeine as an ingredient in food has been regulated by the US Food and Drug Administration (FDA) since 1958, when the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act was enacted. It is li...

Abbreviations CDC US Centers for Disease Control FDA US Food and Drug Administration FR Federal Register FSMA Food Safety Modernization Act GAPs Good Agricultural Practices GMPs Good manufacturing practices HACCP Hazard Analysis and Critical Control Points HARPC Hazard Analysis and Risk-based Preventive Controls LGMA The California Leafy Greens Marketing Agreement USDA US Department of Agriculture

The American Association for Health Freedom (AAHF) and the Alliance for Natural Health (ANH) would like to thank the Food and Drug Administration (FDA) for giving us the opportunity to make this submission. Both organizations, which are formally affiliated, represent a wide range of natural health interests including consumers, food business operators and practitioners in the United States, Eur...