Food and Drug Administration Modernization Act of 1997
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| Long title | A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes. |
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| Acronyms (colloquial) | FDAMA |
| Enacted by | the 105th United States Congress |
| Effective | November 21, 1997 |
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| Public law | 105-115 |
| Statutes at Large | 111 U.S. Stat 2296 |
| Codification | |
| Acts amended | Federal Food, Drug and Cosmetic Act |
| Titles amended | Title 21 USC 301: Food and Drugs |
| Legislative history | |
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The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.
Congressman Richard Burr and Senator James M. Jeffords were the chairperson sponsors of the Food and Drug Administration Regulatory Modernization Act of 1997 or Food and Drug Administration Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton on 21 November 1997, and was fully enacted by 1 April 1999, putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutical drugs.
The FDA Modernization Act of 1997 was a piece of legislation that concentrated on reforming the regulation of food, medical products, and cosmetics in the United States. The following are the most significant provisions of the act:
The act reauthorized, for five more years, the Prescription Drug User Fee Act of 1992 (PDUFA). The purpose of this was to enable the FDA to reduce the average time required for a drug review from 30 months to 15 months.
The law enacts many FDA initiatives undertaken in recent years under Vice President Al Gore's Reinventing Government program. The codified initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application; eliminate the batch certification and monograph requirements for insulin and antibiotics; streamline the approval processes for drug and biological manufacturing changes; and reduce the need for environmental assessment as part of a product application.
The act also codifies FDA regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provides for an expanded database on clinical trials, which will be accessible by patients. With the sponsor's consent, the results of such clinical trials will be included in the database. Under a separate provision, patients will receive advance notice when a manufacturer plans to discontinue a drug on which they depend for life support or sustenance, or for a treatment of a serious or debilitating disease or condition.
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