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FDA新药批准

FDA新药批准

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FDA批注的新药:CDER 的新分子实体和新的治疗性生物产品

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Highlights

The FDA's Center for Drug Evaluation and Research (CDER) is responsible for the evaluation and approval of new molecular entities (NMEs) and new therapeutic biological products (NTBPs). NMEs are new drugs that have not been previously approved for marketing in the United States, while NTBPs are new biological products that have not been previously approved for marketing in the United States. The CDER's mission is to ensure that all new drugs and biological products are safe and effective before they are marketed to the public. The CDER's review process for NMEs and NTBPs is rigorous and comprehensive. It includes a thorough evaluation of the safety and efficacy data submitted by the drug manufacturer. The CDER also conducts its own independent studies to assess the safety and efficacy of new drugs and biological products. Once the CDER has completed its review, it makes a decision on whether or not to approve the drug or biological product for marketing in the United States. If the CDER approves the drug or biological product, it will issue a marketing authorization holder (MAH) to the drug manufacturer. The MAH allows the drug manufacturer to market the drug or biological product in the United States. The CDER's work is essential to ensuring that the public has access to safe and effective drugs and biological products. The CDER's rigorous and comprehensive review process helps to protect the public from harmful drugs and biological products.