Karl, Here's a recent FDA press release (with a link to their timetable of implementing the 1997 FDA Modernization Act, which includes off-label use changes):
Press Office
Food and Drug Administration
U.S. Department of Health and Human Services
NOTE TO CORRESPONDENTS Print Media: 301-827-6242
February 10, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
FDA POSTS IMPLEMENTATION CHART FOR THE
FDA MODERNIZATION ACT OF 1997 ON ITS
WEBSITE
FDA has posted on its Website (at URL fda.gov 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.Press Office
Food and Drug Administration
U.S. Department of Health and Human Services
NOTE TO CORRESPONDENTS Print Media: 301-827-6242
February 10, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
FDA POSTS IMPLEMENTATION CHART FOR THE
FDA MODERNIZATION ACT OF 1997 ON ITS
WEBSITE
FDA has posted on its Website (at URL fda.gov 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. |
