URL:
"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm"
Here is the introduction and a few summaries:
Development & Approval Process (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.
Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
Guidance Documents for Drug Applications
Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
For the complete list of CDER guidances, please see the Guidance Index.
The Investigational New Drug Application Process web page has an updated list of all guidances to help in the preparation of IND applications.
Guidance Document for Emergency INDs
The Guidance for Institutional Review Boards and Clinical Investigators contains information on: Obtaining an Emergency IND, Emergency Exemption from Prospective IRB, Approval Exception From Informed Consent, and Requirement Planned Emergency Research, Informed Consent Exception.
The New Drug Application Process web page has an updated list of all guidances to help in the preparation of NDA applications.
- The Abbreviated New Drug Application Process web page has an updated list of all guidances to help in the preparation of ANDA applications.
Laws, Regulations, Policies and Procedures for Drug Applications
The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. The law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.
Code of Federal Regulations for Investigational New Drugs (INDs), New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
The following sections provide regulations for INDs and NDAs. All parts of section 21 of the Code of Federal Regulations are also available.
Manual of Policies and Procedures ().
The following MaPPs provide official instructions for internal practices and procedures followed by CDER staff to help standardize the IND and NDA review process. All CDER MaPPs are available from the MaPP Index webpage.
How Drugs are Developed and Approved
The Center for Drug Evaluation and Research's (CDER) job is to ensure that drugs are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
CDER is the largest of FDA's five centers. It has responsibility for both prescription and over-the-counter drugs. For more information on CDER activities, including performance for drug reviews, post-marketing risk assessment, and other highlights, please see the CDER Update: Improving Public Health Through Human Drugs The other four FDA centers have responsibility for medical and radiological devices, food, and cosmetics, biologics, and veterinary drugs.
It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's new drug application (NDA) containing the data and proposed labeling.
The section below entitled From Fish to Pharmacies: The Story of a Drug's Development, illustrates how a drug sponsor can work with FDA's regulations and guidance information to bring a new drug to market.
Osteoporosis, a crippling disease marked by a wasting away of bone mass, affects as many as 2 million American, 80 percent of them women, at an expense of $13.8 billion a year, according to the National Osteoporosis Foundation., The disease may be responsible for 5 million fractures of the hip, wrist and spine in people over 50, the foundation says, and may cause 50,000 deaths. Given the pervasiveness of osteoporosis and its cost to society, experts say it is crucial to have therapy alternatives if, for example, a patient can't tolerate estrogen, the first-line treatment.
Enter the salmon, which, like humans, produces a hormone called calcitonin that helps regulate calcium and decreases bone loss. For osteoporosis patients, taking salmon calcitonin, which is 30 times more potent than that secreted by the human thyroid gland, inhibits the activity of specialized bone cells called osteoclasts that absorb bone tissue. This enables bone to retain more bone mass.
Though the calcitonin in drugs is based chemically on salmon calcitonin, it is now made synthetically in the lab in a form that copies the molecular structure of the fish gland extract. Synthetic calcitonin offers a simpler, more economical way to create large quantities of the product.
FDA approved the first drug based on salmon calcitonin in an injectable. Since then, two more drugs, one injectable and one administered through a nasal spray were approved. An oral version of salmon calcitonin is in clinical trials now. Salmon calcitonin is approved only for postmenopausal women who cannot tolerate estrogen, or for whom estrogen is not an option.
How did the developers of injectable salmon calcitonin journey "from fish to pharmacies?"
After obtaining promising data from laboratory studies, the salmon calcitonin drug developers took the next step and submitted an Investigational New Drug (IND) application to CDER. The IND Web page explains the need for this application, the kind of information the application should include, and the Federal regulations to follow.
Once the IND application is in effect, the drug sponsor of salmon calcitonin could begin their clinical trials. After a sponsor submits an IND application, it must wait 30 days before starting a clinical trial to allow FDA time to review the prospective study. If FDA finds a problem, it can order a "clinical hold" to delay an investigation, or interrupt a clinical trial if problems occur during the study.
Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause. The Running Clinical Trials Webpage provides links to the regulations and guidelines that the clinical investigators of salmon calcitonin must have used to conduct a successful study, and to protect their human subjects.
The salmon calcitonin drug sponsor analyzed the clinical trials data and concluded that enough evidence existed on the drug's safety and effectiveness to meet FDA's requirements for marketing approval. The sponsor submitted a New Drug Application (NDA) with full information on manufacturing specifications, stability and bioavailablility data, method of analysis of each of the dosage forms the sponsor intends to market, packaging and labeling for both physician and consumer, and the results of any additional toxicological studies not already submitted in the Investigational New Drug application. The NDA Web page provides resources and guidance on preparing the NDA application, and what to expect during the review process.
New drugs, like other new products, are frequently under patent protection during development. The patent protects the salmon calcitonin sponsor's investment in the drug's development by giving them the sole right to sell the drug while the patent is in effect. When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions. The Abbreviated New Drug Applications (ANDA) for Generic Drug Products Webpage provides links to guidances, laws, regulations, policies and procedures, plus other resources to assist in preparing and submitting applications.
Drug sponsors from small businesses can take advantage of special offices and programs designed to help meet their unique needs. The Small Business Assistance Webpage provides links to FDA laws, regulations and guidances that affect small business. Information is also provided on financial assistance and incentives that are available for drug development.
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