New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products | |||
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분류 | New drug | 조회 | 2290 |
발행년도 | 2015 | 등록일 | 2015-07-10 |
출처 | FDA (바로가기) | ||
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.
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이전글 | 상악동 골이식술을 위한 동종골이식재의 유효성과 안전성 평가를 위한 임상시험 방법 |
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다음글 | Investigational New Drug (IND) Application |