Center For Drug Evaluation and Research

History Federal regulation of drugs emerged as early as 1848, under a law that addressed only imported drugs. In 1905 the American Medical Association launched a private, voluntary means of controlling a substantial part of the drug marketplace, a system that remained in place for over a half-century. Drug regulation in FDA has evolved considerably since President Theodore Roosevelt signed the 1906 Pure Food and Drugs Act.

About the Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

CDER office and division

Office of center director Controlled Substances Staff Mission The mission of the Controlled Substance Staff (CSS) is to promote the public health through the medical science-based assessment and management of drug abuse risks. CSS accomplishes this mission by performing specific functional roles1, including providing consultation services to CDER Review Divisions and acting as the CDER and FDA liaison to other government organizations.

Office of compliance
Mission: To promote and protect public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs. Vision: Through excellence in risk- and science-based policy, surveillance, and enforcement, we prevent consumer exposure to unnecessary risk from drugs throughout their lifecycle.

Office of New Drugs

The Office of New Drugs (OND) is responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. We also provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

Office of Drug Evaluation III (ODE III)

Mission Office of Drug Evaluation III is responsible for protecting the public health by assuring safe and effective drugs and biologics are available to the U.S. population for dermatology, dental, gastroenterology, reproductive, and urologic uses and for in-born-errors of metabolism and conditions involving bone metabolism.

Office of Pharmaceutical Science (OPS)

The Office of Pharmaceutical Science (OPS) is an umbrella organization over the activities of chemistry manufacturing and controls (CMC) review in CDER. This includes assessment of product and process design, evaluation of product quality in light of established standards and setting and maintaining new quality standards. OPS is an integral part of CDER's new and generic drug product application review process. Staff working in these groups have backgrounds in chemistry, biology, bio pharmaceutics, clinical pharmacology, immunology, pharmaceutical science, microbiology, pharmacology/toxicology and labelling.

Office of Pharmaceutical Science (OPS)

The goal of OPS is to help establish common approaches to the manufacture and formulation of drugs among pharmaceutical manufacturers. OPS contributes to assuring the quality of drug products by providing uniform policies and review processes for the entire pharmaceutical industry through:

Office of biotechnology products

Description The mission of the Office of Biotechnology Products is to protect public health by assuring the quality, safety, efficacy, availability and security of therapeutic protein and monoclonal antibody products.

Office of new drug quality assessment

Description Overview: The Office of New Drug Quality Assessment (ONDQA) assesses the critical quality attributes and manufacturing processes of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development. The Office of New Drug Quality Assessment focuses on critical pharmaceutical quality attributes (chemistry, pharmaceutical formulation, stability, manufacturing processes, bioavailability, product performance) and their relevance to safety and efficacy.

Office of new drug quality assessment

ONDQA emphasizes quality by design in the evaluation of critical aspects of pharmaceutical quality; has a strong focus on manufacturing science; integrates review and inspection functions; and uses modern statistical methodologies. Mission: ONDQA assesses the critical quality attributes and manufacturing processes of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development.

Office of Surveillance and Epidemiology (OSE)

Mission CDER evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. We maintain a system of post marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. We learn about adverse events through required reporting by companies and through voluntary reports submitted to FDA s MedWatch program, which together total more than 250,000 reports per year.

Office of Surveillance and Epidemiology (OSE)

Staff in the Office of Surveillance and Epidemiology use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health. Activities include updating drug labelling providing more information to the community implementing or revising a risk management program on rare occasions, re-evaluating approval or marketing decisions CDER also works with drug companies to reduce medication errors related to confusing labels, labelling, drug packaging, and drug names that look alike or sound alike.

Office of Translational Sciences

Mission The Office of Translational Sciences (OTS) promotes and protects public health by assuring that safe and effective drugs are available to Americans by: Developing and applying quantitative and statistical approaches to decision making in the regulatory review process Assuring the validity of clinical trial design and analysis in regulatory decision making Promoting innovation in drug regulatory review across CDER via Critical Path Initiatives Promoting scientific collaboration to advance regulatory review

Office of Translational Sciences

Overview OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety, and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. We foster novel drug development strategies through research and application of statistical and mathematical modeling and simulation techniques in the review and analysis of data in the areas of exposure-response, pharmacokinetics, pharmacodynamics, pharmacogenomics, bioequivalence assessment, clinical trials, quantitative risk assessment, toxicology, and product quality assessment.

CDER Office Of Biostatistics

Introduction As a member of the Office of Translational Sciences (OTS) within the Center for Drug Evaluation and Research (CDER), the Office of Biostatistics (OB) provides CDER with statistical leadership, expertise, and advice to assure that safe and effective drugs are available to the American people. The Biostatistics Program is recognized as a center of excellence for the development, research, application, and communication of statistical methodology for drug regulation and development.

Office of Clinical Pharmacology (OCP)

The mission of the Office of Clinical Pharmacology (OCP) is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and bio pharmaceutics data in support of the Center for Drug Evaluation and Research's Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs. Through research, we assure that regulatory policy and decision making are based on the best available science.

 What OCP DO? Evaluate what the body does to the drug and what the drug does to the body Understand inter-patient variabilities that relate to benefit and risk Optimize dose and dose regimen to balance benefit and risk Translate knowledge from NDA/BLA reviews into labelling language that is understandable and actionable Conduct research to expand our knowledge of clinical pharmacology to better evaluate benefit and risk

WHAT CDER DO?

Improving Public Health : Promoting Safe and Effective Drug Use The FDA s Center for Drug Evaluation and Research(CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. CDER evaluate all new drugs before they are sold, and serves as a consumer watchdog for the more than10,000 drugs on the market to be sure they continue to meet the highest standards. The center routinely monitors TV, radio, and print drug ads to ensure they are truthful and balanced. CDER also plays a critical role in providing health professionals and consumers information to use drugs appropriately and safely.

What CDER do?

Strong FDA Strong and sound science means CDER scientists stay on the cutting edge of new technologies. The center s mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians, project managers and other highly qualified and dedicated professionals.

What CDER do?

Efficient risk management In 2002, CDER evaluated many new drugs that offered important treatment options for Americans. However, it is of concern that the approval of truly new drugs is at the lowest level in a decade. The center has launched two important initiatives to remove barriers to innovation in drug development and to facilitate the modernization of American drug manufacturing.

WHAT CDER DO?

Patient and consumer safety CDER continued to enhance its drug safety program to help make sure that drugs are used safely once they re approved. The centre alerted the public to the dangers of importing or buying over the Internet 10drugs that are marketed in this country with special safety restrictions

What CDER do?

Better consumer information CDER is collaborating with abroad spectrum of groups to improve information for prescribers and consumers. Industry and consumers are increasingly turning to the CDER Internet site for important and up-to-date information on the center s regulatory programs and on the drugs they take to improve their health.

What CDER do?

Counterterrorism CDER continues to facilitate development of new drugs and new uses for already-approved drugs that could be used as medical countermeasures.

CDER
CDER: The Consumer Watchdog for Safe and Effective Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The center's best-known job is to evaluate new drugs before they can be sold. The center's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

 The Beginnings: Laboratory and Animal Studies The drug research process is complicated, time-consuming, and costly; and the end result is never known at the outset. Literally hundreds, and sometimes thousands, of chemical compounds must be made and tested to find one that can achieve the desirable result without too Serious side effects. Such a complicated process costs vast amounts of time and money. The FDA estimates that, on average, it takes eightand-a-half years to study and test a new drug before the agency can approve it for the general public. That includes early laboratory and animal testing, as well as later clinical trials using human subjects.

 The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasn't until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.

 Advisory Committees: Critical to the FDA's Product Review Process The Food and Drug Administration regulates more than 150,000 marketed drugs and medical devices. At any time, nearly 3,000 investigational new drugs are being developed. More dietary supplements than ever before are on the market, and Americans today have a much broader range of food choices. Then there are the scores of blood products and veterinary medicines for which the FDA is responsible. Access to this growing range of products offers opportunities for advancing public health and improving people's lives. But it also creates new vulnerabilities and greater potential risks for people who use the products. To keep up with the challenges that the FDA's full-time experts face when reviewing innovative and rapidly evolving technologies, the agency hires "special government employees" whose opinions complement its goals to provide safe and effective products.

 OTC Drug Facts Label Whenever you use an over-the-counter (OTC) medicine, reading the drug product's labelling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do, who should or shouldn't take it, and how to use it. The labelling of OTC medicines has always contained usage and safety information for consumers. With the introduction of the "Drug Facts" label, the information is more uniform and easier to read and understand.

 How to Obtain Information About Prescription and Over-theCounter Drugs The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is a knowledge warehouse. Do you want to know about potential drug-drug interactions, or the possibility of side effects? Do you have questions about the effectiveness of the latest baldness cure? If you are not even sure what questions to ask your health care provider or if you just wonder what fluoride really does for the teeth, CDER's Division of Drug Information can provide you with answers to these and hundreds of other questions that you may have about drugs.

 Cont.. Regulating Drugs Thousands of people call or write the FDA each year for information about drugs regulated by CDER. From aspirin to cancer treatments, CDER ensures that the benefits of drug products outweigh the known risks. The center has oversight responsibilities for human prescription, over the counter, and generic drugs. This responsibility includes products that many consumers usually do not consider to be drugs, such as fluoride toothpaste, sunscreens, and dandruff shampoos.

Cont May I Help You? Located in the FDA's agency headquarters, the Division of Drug Information is the focal point for inquiries by pharmacists, doctors, nurses, pharmaceutical and insurance companies, federal agencies, consumers, and other constituencies. Over the years, the division has answered an average of 4,000 telephone calls, 600 letters, and 2,800 e-mails per month. Staffed with pharmacists and other health care professionals experienced with drug related topics, the division's consumer safety officers (CSOs) consult with all areas of the FDA to get the most current information necessary to answer often detailed and complicated questions.

 Cont The staff services include: responses to questions from health care professionals and consumers "Approval" and "Hot Topic" information providing overviews of center responsibilities to visiting foreign government officials regulatory guidance to the pharmaceutical industry drug identification liaison with CDER's divisions and compliance office to identify and resolve issues of drug availability.

 Written Material In addition, the team is the storehouse for all CDER publications, Federal Register notices, drug product inserts, consumer articles, recall notices, and other drug related information. As a follow-up to speaking with a health care professional, a CSO can usually give callers additional information. In addition, CSOs can help the caller navigate the CDER Web site or send articles, brochures, press releases, federal regulations, fact sheets, and other publications. Strict Confidence By law, FDA employees cannot release confidential information about unapproved drugs or clinical trials. Consumers should obtain this information from physicians, private/non profit organizations, or pharmaceutical companies

 How to Obtain Information To obtain information or ask specific questions about your condition, prescription, and over-the-counter drugs, or related topics, you should consult a health care professional. If you need more information, checkout CDER's Web page at www.fda.gov/cder/1 or contact the FDA's Center for Drug Evaluation and Research (CDER) directly. Or contact the division via e-mail. Send your question to druginfo@cder.fda.gov