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About CDER (Center for Drug Evaluation and Research/FDA) Browse this site for information related to the programs and services of the Center for drug Evaluation and Research (CDER). Includes data, research findings, regulations, career opportunities at CDER... Details > Center for Drug Evaluation and Research, U.S. Food and Drug Administration | Approved Drug Products with Therapeutic Equivalence Evaluations This publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on... Details > Center for Drug Evaluation and Research, U.S. Food and Drug Administration | Drug Information Home Page - Center for Drug Evaluation and Research This page links users to CDER material and resources available online. Includes a drug code directory, information on drug labeling changes, adverse drug reaction reporting data, and information on ... Details > Center for Drug Evaluation and Research, U.S. Food and Drug Administration | FAQ - About the Drug Pricing Program This web site offers an overview of the Bureau of Primary Health Care's (BPHC) Drug Pricing Program and answers questions commonly asked by facilities that want to get discount drug prices.... Details > Office of Pharmacy Affairs, Bureau of Primary Health Care/HRSA | Over-the-Counter Drug Review Process An interactive chart that provides an overview of CDER's over-the-counter drug review process, and how CDER determines the safety and effectiveness of OTC drug products.
... Details > Center for Drug Evaluation and Research, U.S. Food and Drug Administration | Warning Letters and Notice of Violation Letters to Pharmaceutical Companies These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. Some of the letters have been redacted or edited to remove confidential information.... Details > Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
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