To be regulated by the FDA, foods, cosmetics, human and animal drugs, biologics, tissues, medical devices, combination products, and tobacco products have to meet the federal public health definitions. This white paper provides an overview of past and present U.S. public health laws and regulations and their impact on FDA-regulated products and industries. It highlights the role of the FDA and discusses the historical context behind the enactment of public health laws, such as the 1906 Food and Drugs Act and the 1938 Food, Drug, and Cosmetic Act, as well as subsequent amendments and acts. It emphasizes the importance of ensuring the safety and effectiveness of regulated products through requirements for clinical studies, post-market surveillance, adverse event reporting, and risk monitoring.
There are exciting and challenging times as a result of the enactment of the 2022 FDORA, and drug manufacturers need to be aware of the ever-changing regulatory framework and evolving nature of public health laws. Download the full white paper to learn more.
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