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1999 FDA'S ROLE IN ADMINISTERING THE HATCH-WAXMAN ACT 211 FDA's Role in Administering the Hatch-Waxman Act BRIAN J. MAL KIN* The Food and Drug Administration (FDA) works extensively with the U.S.
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The FDA's role in administering is to regulate and ensure the safety of food, drugs, medical devices, cosmetics, and other products to protect public health.
Companies and individuals involved in the manufacturing, distribution, and sale of regulated products are required to file with the FDA.
To fulfill the FDA's role in administering, companies and individuals must comply with the specific regulations and guidance applicable to their respective industries.
The purpose of the FDA's role in administering is to protect and promote public health by ensuring the safety, efficacy, and quality of regulated products.
The specific information that must be reported to the FDA depends on the type of product and the applicable regulations, but generally includes manufacturing processes, ingredients, labeling, and adverse events.
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