CDER 2007 Update - Appendix

Drug Definitions

Drug Review Definitions

Prescription Drugs

Over-the-counter Drugs

Generic Drugs

New Drug Applications

Biologic License Applications

CDER 2007 Update
Appendix
Glossary of Terms

We regulate drugs used to treat, prevent or diagnose illnesses. However, drugs include more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered “drugs.” You can buy some drugs in a store without a prescription, while others require a doctor’s prescription. Some are available in less-expensive generic versions.

Prescription medicines must be administered under a doctor’s supervision or require a doctor’s authorization for purchase. There are several reasons for requiring a medicine be sold by prescription:

The disease or condition may be serious and require a doctor’s management.
The medicine itself may cause side effects that a doctor needs to monitor.
The same symptoms may be caused by different diseases that only a doctor can diagnose.
The different causes may require different medicines.
Some medicines can be dangerous when used to treat the wrong disease.

You can buy over-the-counter drugs without a doctor’s prescription. You can successfully diagnose many common ailments and treat them yourself with readily available OTC products. These range from acne products to cold medications. As with prescription drugs, we closely regulate OTC drugs to ensure that they are safe, effective and properly labeled.

A generic drug is a chemical copy of a brand-name drug. There are generic versions of both prescription and over-the-counter drugs. Generic drugs approved by the FDA have the same therapeutic effects as their brand-name counterparts, often at much lower cost.

Review and approval times. Review time is time spent examining the application. Approval time represents review time plus industry’s response time to our requests for additional information.
Priority reviews. These products represent significant improvements compared with marketed products. We have a goal of reviewing 90 percent of these applications within six months.
Standard reviews. These products have therapeutic qualities similar to those of already marketed products. We have a goal of reviewing 90 percent of these applications within 10 months.
Actions and filings. An application is filed when we determine it is complete and accept it for review. We make a filing decision within 60 days of receiving an application. Approval is one of the actions that we can take once an application is filed. Another action is seeking more information from the sponsor. There is no direct connection between applications filed in one year and actions in the same year.
Orphan drugs. We administer a program that provides incentives to develop drugs for use in patient populations of 200,000 or fewer. Sponsors of orphan drugs receive the following inducements: seven-year marketing exclusivity, tax credit for the product-associated clinical research, research design assistance from FDA and grants of up to $200,000 a year.
Accelerated approval. This program makes products for serious or life-threatening diseases available earlier in the development process by relying on an effect on a surrogate end point to predict clinical benefit. An effect of the drug on a surrogate end point can be observed significantly sooner than can a long-term clinical benefit. Sponsors must perform additional studies to demonstrate long-term clinical benefit.
Fast-track development. This program facilitates the development and expedites our review of new medicines that demonstrate the potential to address unmet medical needs for serious or life-threatening conditions. Fast track emphasizes our close, early communication with sponsors.
Median times. Our charts show review and approval times as medians. The value for the median time is the number that falls in the middle of the group after the approval times are ranked in order. It provides a truer picture of our performance than average time, which can be unduly influenced by a few very long times. Our guide to understanding median approval time statistics is available at http://www.fda.gov/cder/present/MedianAPtime/index.htm.
Tentative approval. This program is issued to the drug company when the application is approvable prior to the expiration of any patents or exclusivities accorded to the reference listed drug product. A tentative approval does not allow the applicant to market the product and postpones the final approval until all patent or exclusivity issues have expired.
New Molecular Entities (NMEs) contain an active substance that has never before been approved for marketing in any form in the United States. Because of high interest in truly new medicines, we report approvals of NMEs and new biologic license applications (BLAs). The charts for all new drug applications (NDAs) and all BLAs include NMEs and new BLAs.

NDAs are the formal submissions of data that sponsors send us when they are seeking approval to market a new drug in the United States. Some NDAs are for NMEs; however, NDAs can also be for an active substance previously sold in a different form.

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BLAs are the formal submissions of data that sponsors send us when they are seeking approval to market a biologic in the United States. A new BLA is an application for a biologic that has never been approved for marketing in the United States.

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Date created: July 31, 2008