Innovation drives progress. When it comes to innovation in the
development of new drugs and therapeutic biological products, FDA’s
Center for Drug Evaluation and Research (CDER) supports the
pharmaceutical industry at every step of the process. With its
understanding of the science used to create new products, testing and
manufacturing procedures, and the diseases and conditions that new
products are designed to treat, FDA provides scientific and regulatory
advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new
treatment options for patients and advances in health care for the
American public. For this reason, CDER supports innovation and plays a
key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological
products. Some of these products are innovative new products that never
before have been used in clinical practice. Others are the same as, or
related to, previously approved products, and they will compete with
those products in the marketplace.
Certain drugs are classified as new molecular entities (“NMEs”) for
purposes of FDA review. Many of these products contain active moieties
that have not been approved by FDA previously, either as a single
ingredient drug or as part of a combination product; these products
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 purposes of 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 an “NME” for review purposes is distinct from FDA’s
determination of whether a drug product is a “new chemical entity” or
“NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
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