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A: Drugs intended for human use are evaluated by FDA's Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective.

The FDA must regulate and approve new prescription drugs before they can be sold to the public.

The drug sponsor formally asks FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. After an NDA is received, FDA has 60 days to decide whether to file it so it can be reviewed.

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services.

FDA enforces the Federal Food, Drug and Cosmetic Act (FD&C Act) and other related acts. This page provides an overview of FDA's import compliance and enforcement activities at the point of entry. FDA has jurisdiction over imported products at the time of entry but also after the products have entered domestic commerce.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. MAPPs are required by law and made available to the public to make CDER a more transparent organization. A MAPP may be removed from this FDA.gov page while it is being evaluated and updated.