Implementation Chart for FDA Modernization Act of 1997
The U.S. FDA has posted on its website a comprehensive chart detailing the many tasks it is required to implement under the Food and Drug Administration Modernization Act of 1997 (Public Law No. 105-115). This law required FDA to undertake dozens of regulatory and program initiatives related to the regulation of drugs, foods, biologics, and medical devices.
This website chart lists tasks that are specifically required by the statute as well as those that the agency has deemed necessary to assure the effective implementation of this law. Each listing on the chart will highlight a particular initiative being taken to implement the law. This listing will be accompanied by information about the specific section of the statute that is being addressed, a description of the initiative, the deadline listed in the statute for that initiative (where applicable), and the name of the person at FDA who can be contacted regarding this initiative.
In addition to this chart, FDA will make regular public announcements about the overall status of this effort as major initiatives are put in place and completed over the months to come.
To obtain a printed copy of this chart, call FDA's Office of Policy at 301-827-3360. To download or view a copy, visit the FDA's website at: www.fda.gov/po/modact97.html.
Edited by Angelo DePalma