DPAMS CDER Meaning and
Definition
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DPAMS CDER stands for Drug Product Application Management System- Center for Drug Evaluation and Research. It is an electronic system used by the United States Food and Drug Administration (FDA) to manage the application process for drug product submissions.
DPAMS CDER is an integral part of the FDA's regulatory review process for reviewing, evaluating, and approving new drug products for marketing in the United States. It allows pharmaceutical companies and sponsors to submit applications for new drug products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs).
This electronic system streamlines the submission process by allowing applicants to submit their applications online, eliminating the need for paper submissions. DPAMS CDER provides a centralized platform for submission tracking, review, and communication between the FDA and the applicant. It enables the FDA reviewers to access the submitted data and documents, evaluate the safety and efficacy of the drug product, and make decisions based on the provided information.
Furthermore, DPAMS CDER also facilitates the communication between the FDA and the applicant during the review process. It allows the FDA to request additional information or clarification on certain aspects of the application and for the applicant to respond promptly. Ultimately, DPAMS CDER helps ensure the efficient and timely evaluation of drug products, aiding in the FDA's mission to protect public health by ensuring the safety, efficacy, and quality of drug products in the United States.
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