The availability of new drugs and biological products often means new treatment options for patients and advances in health care. Each year, FDA's Center for Drug Evaluation and Research (CDER) approves a wide range of new drugs and biological products. Some of these products are innovative new products that have never been used in clinical practice. Other approved products are either similar to or related to, previously approved products, and they will compete with the existing ones in the market.

Certain drugs are classified as new molecular entities ("NMEs") for purpose of FDA review. Many of these products contain active moieties that have not been approved by FDA earlier, either as a single ingredient drug or as part of a combination product; but they frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA's classification of a drug as a "NME" for review purposes is distinct from its determination whether a drug product is a "new chemical entity" (NCE) within the meaning of the Federal Food, Drug, and Cosmetic Act.

Download >> United States Food And Drug Administration (US-FDA): Novel Drug Approvals For 2017

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