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ANDA is an application for a U.S. generic drug approval for an existing approved or licensed drug. An ANDA contains data for review and possible approval of a generic drug product. They are not usually required to contain preclinical and clinical trial data to establish the efficacy and safety of the drug. However, generic drug applicants must scientifically demonstrate that their product is bioequivalent to the innovator/brand drug through some methods, such as measuring the time it takes for the generic drug to reach the bloodstream of healthy volunteers. https://www.proregulations.com/u-s-abbreviated-new-drug-application-anda.html

According to laws and regulations such as The Food, Drug and Cosmetic Act and Code of Federal Regulations Title 21, the new drug review process of the US Food and Drug Administration (FDA) includes two parts: IND application for new drug clinical trials and NDA application for new drug marketing. https://www.proregulations.com/u-s-new-drug-application-nda.html

The United States recently enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which expands the FDA's regulatory authority over the cosmetics industry. This new law requires the FDA to establish comprehensive regulations for companies that manufacture and distribute cosmetics in the U.S. https://www.proregulations.com/us-fda-cosmetics-registration.html