FDA Modernization Act

The FDA Modernization Act of 1997 contains a requirement for public disclosure and congressional reporting by October 2001 of Phase IV studies. FDA intends to meet the public disclosure requirement by posting Phase IV study commitments, the projected end of the study, and the current status of the study on their web site [102]. Sponsors whose new drug was approved with a Phase IV study requirement must submit an initial status report to FDA within one year of approval. According to data compiled by Public Citizen s Health Research Group [103], not one of the Phase IV study commitments for 107 new molecular entities approved between January 1995 and December 1999 had been completed as of December 1999. 

Marwick, C. (1998). Implementing the FDA modernization act (Medical News and Perspectives). JAMA 279 815-816. 

Advisory committees. There is no statutory requirement that FDA review the approval of an NDA with an advisory committee before final action is taken. Since the 1970s, however, this has been the customary practice, particularly with important new drugs. This prompted Congress to enact a specific provision dealing with the establishment of drug advisory committees under the FDA Modernization Act of 1997. The review of an NDA by an advisory committee is an extremely important step in the approval process. It represents the best opportunity that the applicant has to address the agency and the public about the evidence of safety and effectiveness and the importance of the drug to public health. In the vast majority of cases, FDA accepts the recommendation of the advisory... 

The non-prescription drug industry traded records inspection for national uniformity under the FDA Modernization Act of 1997, 111 Stat. 2296, 2374, 2375 (1997). 

In 1990, the Institute of Medicine sponsored a workshop to address the lack of pediatric labeling. This workshop produced recommendations that eventually led to the pediatric provisions of the FDA Modernization Act (FDAMA) of 1997, as well as to the 1998 FDA Pediatric Rule (FDAMA, 1999). Stimulated by FDAMA and the 1998 Rule, researchers have devel-... 

FDA Modernization Act (1997). This act contains some of the most sweeping changes to the Food, Drug and Cosmetic Act. The act contains changes in how user fees are assessed and collected. For example, fees are waived for the... 

U.S. Food and Drug Administration, The FDA Modernization Act of 1997, FDA Backgrounder. Available online. URL http //www.fda.gov/opacom/ backgrounders/modact.htm. Posted November 21, 1997. 

The FDA Modernization Act reauthorizes the Prescription Drug User Fee Act and the system of having drug companies subsidize reviews of... 

Another important component of most vaccine formulations is a suitable preservative. The three most commonly used preservatives in available vaccines are phenol, 2-phenoxyethanol, and ethyl mercurithiosalicylate (thimerosal). Thimerosal, in particular, is used in multidose vials as an antimicrobial preservative. Concerns about the presence of mercury in thimerosal (25 pg/dose) has led to FDA stopping the use of this preservative in all vaccines by an amendment to the FDA Modernization Act of 1997. By 2001, thimerosal was removed from most childhood vaccines as a precautionary measure. The sources of all of the preservatives for vaccines are the same suppliers that supply preservatives for the parenteral dosage forms (J. T. Baker, Aldrich, Spectrum, etc. from U.S.A.). Table 2 lists some of the preservative concentrations in common vaccines. 

Fast track program This program was added under the FDA Modernization Act of1997 as an extension of the accelerated drug and biologic product approval process. It was designed to facilitate development and expedite review for products that demonstrate potential or unmet medical needs in the treatment of serious or life-threatening conditions. 

Phase IV commitments are agreements made between the agency and sponsors to conduct postapproval studies for the purpose of gathering further safety and efficacy information. Under the FDA Modernization Act of 1997, applicants are required to submit annual reports on the status of postmarketing commitments. Additionally, under FDAMA, marketing an approved product for off-label claims would be allowed, providing one or more clinical study corrobates safety and efficacy. 

Trends Over Time The FDA Modernization Act, Team Biologies, New Medical Device Regulations, and Quality Systems Inspection (QSI)... 

Until the new guidelines are released, the FDA is operating under section 103(a) of Title I of the FDA Modernization Act of 1997, final rule on postmarketing study requirements (October 30, 2000 65 FR 64607), which became effective on April 30,2001. 

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