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The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate. [1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority ...
The history of early food regulation in the United States started with the 1906 Pure Food and Drug Act, when the United States federal government began to intervene in the food and drug businesses. When that bill proved ineffective, the administration of President Franklin D. Roosevelt revised it into the Federal Food, Drug and Cosmetic Act of ...
Food, Drug, Cosmetic Law Journal. 45 (3). Food and Drug Law Institute: 301– 317. JSTOR 26659048. Benson, James S (May 1990). "Improving the Generic Drug Regulatory System". Food, Drug, Cosmetic Law Journal. 45 (3). Food and Drug Law Institute: 207– 217. JSTOR 26659239. Hatch, Orrin G (April 1983). "Areas for Change in the Food and Drug Laws".
The Pure Food and Drug Act forced food manufacturers to only sell unadulterated foods and to correctly label foods. The Meat Inspection Act lead to the creation of the US Department of Agriculture's Food Safety and Inspection Service, which manages the production of meat, poultry, and eggs, enforcing regulated limits of certain contaminants and ...
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency had ...
328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New animal drugs; 556 Tolerances for residues of drugs in food animals; The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health ...
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the ...