FDA Center for Drug Evaluation and Research

Company Overview
The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) oversees the research, development, manufacture and marketing of drugs. CDER reviews new drug applications for prescription, over-the-counter and generic drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label or, if necessary, remove a product from the market. CDER also offers regulatory and scientific guidance documents such as the CDER Data Standards Manual and current good manufacturing practice notes, as well as information on patents and exclusivity; pharmacology and toxicology; specific regulatory initiatives; legislation; submission of drug applications; and compliance activities.

Quick Facts
FDA Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, MD 20857

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• Improving Public Health Through Human Drugs by FDA Center for Drug Evaluation and Research
  This 2004 report from the FDA's Center for Drug Evaluation and Research (CDER) discusses how to develop new medicines efficiently without compromising safety and effectiveness, and identifying and managing issues related to the safe use of approved medicines.
  
  
• Good pharmacovigilance practices and pharmacoepidemiologic assessment by FDA Center for Drug Evaluation and Research
  This white paper by the Center for Drug Evaluation and Research (CDER) provides guidance on good pharmacovigilance practices and pharmacoepidemiologic assessment.
  
  
• Development and use of risk minimization action plans by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research provides guidance on developing and implementing risk minimization plans for prescription drug products.
  
  
• Requesting methods validation for abbreviated new drug applications by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research (CDER) describes situations in which review chemists should submit abbreviated new drug applications (ANDAs).
  
  
• Risk-based method for prioritizing cGMP inspections of pharmaceutical ... by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) explains the pilot risk ranking model, a risk-based method for prioritizing current good manufacturing practices (cGMPs) inspections of pharmaceutical manufacturing sites.
  
  
• Guidance for industry PAT — A framework for innovative pharmaceutical ... by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is a guidance for industry on process analytical technology (PAT) and represents the FDA's current thinking on this topic.
  
  
• Challenge and opportunity on the critical path to new medical products by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research (CDER) analyzes the pipeline problem in innovative medical therapies reaching patients and calls for a joint effort of industry, academia and the FDA to develop solutions.
  
  
• Guidance for industry and FDA: Current good manufacturing practice for ... by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research explains current good manufacturing practices for combination products.
  
  
• Sterile drug products produced by Aseptic processing — Current good ... by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research discusses current good manufacturing practice regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing.
  
  
• Formal dispute resolution: Scientific and technical issues related to ... by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) provides guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (cGMP) requirements.
  
  
• Bioanalytical method validation by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research (CDER) provides guidance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability and bioequivalence studies requiring pharmacokinetic evaluation.
  
  
• Bioavailability and bioequivalence studies for orally administered drug ... by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research (CDER) contains advice on how to meet the bioavailability and bioequivalence requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration, including INDs, NDAs, ANDAs, and their supplements.
  
  
• Guidance for submitting influenza resistance data by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research (CDER) offers guidance for submitting influenza resistance data.
  
  
• Guidance for submitting hepatitis C virus (HCV) resistance data by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is guidance for submitting hepatitis C virus (HCV) resistance data.
  
  
• Guidance for submitting HIV resistance data by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is guidance for submitting human immunodeficiency virus (HIV) resistance data.
  
  
• Guidance for submitting HBV resistance data by FDA Center for Drug Evaluation and Research
  This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is guidance for submitting hepatitis B virus (HBV) resistance data.
  
  
• Applications of PAT to crystallization processes by FDA Center for Drug Evaluation and Research
  This white paper by the FDA's Center for Drug Evaluation and Research describes the application of process analytical technology (PAT) to crystallization processes of active pharmaceutical ingredients (APIs).
  
  
• FDA's Compliance Policy Guide for Pedigree Requirements under 21 CFR Part 203 by FDA Center for Drug Evaluation and Research
  This document is intended to clarify how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203.
  
  
• Guidance for Industry Safety Testing of Drug Metabolites by FDA Center for Drug Evaluation and Research
  This FDA CDER guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.
  
  
• FDA Guidance for Industry: E15 Definitions for Genomic Biomarkers, ... by FDA Center for Drug Evaluation and Research
  This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories.