According to the FDA, the research process is complicated, time-consuming, and costly and the end result is never guaranteed. Literally hundreds and sometimes thousands of chemical compounds must be made and tested in an effort to find one that can achieve a desirable result.

FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects.

The first step in bringing a new drug to market is pre-clinical research. This research takes place in phases and is outlined below.

PreClinical Research Phases

• Synthesis & Purification
• Animal Testing (short-term)
  Generally, two or more species (one rodent, one non-rodent) are tested because a drug may affect one species differently from another.
• Animal Testing (long term)
  Some animal testing continues after human tests begin to learn whether long-term use of a drug may cause cancer or birth defects.
• Institutional Review Boards
  (IRB) are used to ensure the rights and welfare of people participating in clinical trials both before and during their trial participation. IRBs at hospitals and research institutions throughout the country make sure that participants are fully informed and have given their written consent before studies ever begin.
• Phase 1 Clinical Studies
  Includes the initial introduction of an investigational new drug into humans … During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.
• Phase 2 Clinical Studies
  Includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition.
• Phase 3 Clinical Studies
  Are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2...

New Drug Application (NDA)

For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

Essentially, when a pharmaceutical company, for example, invents a new drug, they are required to submit an NDA to the FDA. The FDA then examines the application in order to insure the safety and effectiveness of the drug. If the drug passes the FDA's approval process it then is one step closer to commercialization.

To learn more about the NDA process go to:

• http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/NewDrugApplicationNDAProcess/default.htm

After the Drug is Approved and Goes to Market

Post-Marketing Surveillance The goal of the Center for Drug Evaluation and Research’s (CDER) Post-Marketing Surveillance (PMS) system is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. This is done through a variety of activities and tools that are outlined below. This work is accomplished primarily through CDER's Division of Pharmacovigilance and Epidemiology.

Medication Errors

Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States. Medication mishaps can occur anywhere in the distribution system:

• Prescribing
• Repackaging
• Dispensing
• Administering
• Monitoring

Common causes of such errors include:

• Poor communication
• Ambiguities in product names, directions for use, medical abbreviations or writing
• Poor procedures or techniques
• Patient misuse because of poor understanding of the directions for use of the product

In addition, job stress, lack of product knowledge or training, or similar labeling or packaging of a product may be the cause of, or contribute to, an actual or potential error.

CDER responsibilities are not completed when the safety and effectiveness of a drug product are determined. The Center also has the responsibility for helping to ensure the safe use of the drugs it approves by identifying and avoiding proprietary names that contribute to problems in the prescribing, dispensing, or administration of the product. Because early identification of a potential confusing proprietary name is crucial, CDER reviews these proposed names, prior to approval of a new drug application, by means of the Office of Postmarketing Drug Risk Assessment (OPDRA).

CDER's approach to medication errors is as follows:

• Prevent medication errors prior to a drug's approval
• After approval, evaluate, monitor, and take appropriate action on reports of medication errors
• Educate and provide feedback to health professionals
• Share information with outside organizations involved in preventing medication errors

Recalls

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

Class I recall - situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall - situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall- situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

FDA Warning Letter

An FDA warning letter is a letter issued by the FDA, citing violations identified during its routine or for-cause audit of investigators/study sites. It is a serious notice to an investigator and demands development of effective corrective actions, with the threat of legal penalties if the actions are not impending. Serious repeat violators may be banned by the FDA from performing clinical research on FDA-regulated products. Additionally, the data from any clinical investigator’s site could be rejected from consideration in the FDA submission it is intended to support.

To search through the FDA database of Warning Letters go to: www.fda.gov/foi/warning.htm