FDA News
|
FOR IMMEDIATE RELEASE
October 15, 2008 =
|
Media Inquiries: =
Christopher=20
DiFrancesco, 301-827-6242
Consumer Inquiries:=20
888-INFO-FDA |
FDA Creates Web Page with =
Drug Safety=20
Information for Patients, Health Care Professionals
Consolidates information in one access point =
Consumers and health care professionals can now go to a single page =
on the=20
U.S. Food and Drug Administration's Web site to find a wide variety of =
safety=20
information about prescription drugs. The Web page, http://www.fda.gov/cder/d=
rugSafety.htm,=20
provides links to information in these categories:
- Drug labeling, including patient labeling, professional labeling, =
and=20
patient package inserts;=20
- Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) =
to ensure=20
that their benefits outweigh their risks;=20
- A searchable database of postmarket studies that are required =
from, or=20
agreed to by, drug companies to provide the FDA with additional =
information=20
about a drug's safety, efficacy, or optimal use;=20
- Clinicaltrials.gov, a searchable database of clinical trials, =
including=20
information about each trial's purpose, who may participate, =
locations, and=20
useful phone numbers;=20
- Drug-specific safety information, including safety sheets with the =
latest=20
information about the drug as well as related FDA press announcements, =
fact=20
sheets, and drug safety podcasts;=20
- Quarterly reports that list certain drugs that are being evaluated =
for=20
potential safety issues, based on a review of information in the FDA's =
Adverse=20
Event Reporting System (AERS);=20
- Warning Letters, Import Alerts, Recalls, Market Withdrawals, and =
Safety=20
Alerts;=20
- Regulations and guidance documents;=20
- Consumer information about using medications safely and disposing =
of=20
unused medicines;=20
- Instructions how to report problems to the FDA through its =
MedWatch=20
program;=20
- Consumer articles on drug safety; and=20
- The FDA's response to the Institute of Medicine's 2006 report on =
the=20
future of drug safety.
"By placing Web links to these up-to-date resources on a single page, =
we're=20
helping consumers and health care professionals find drug safety =
information=20
faster and easier," said Paul Seligman, M.D., M.P.H., associate director =
of=20
Safety Policy and Communication in the FDA's Center for Drug Evaluation =
and=20
Research. "This type of communication is aimed at helping consumers and =
health=20
care professionals make well-informed decisions about medication use." =
Establishing such a Web page is one of the requirements of the Food =
and Drug=20
Administration Amendments Act of 2007, and is among FDA's many efforts =
to=20
address the safe use of drugs throughout their lifecycle.
#
RSS Feed=20
for FDA News Releases [what is =
RSS?]=20
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Get=20
email updates about FDA press releases.
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translated +=3D s.substring(i, s.length);
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triggerParms["lf"] =3D 4; // loyalty factor
triggerParms["sp"] =3D 0; // sample percentage
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triggerParms["ascookie"] =3D "ForeseeSurveyShown_oFU8oht9h8";
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triggerParms["aro"]=3D 0; //user has chosen to use Auto Retry Option, =
with SP=3D100
//triggerParms["rct"]=3D 1; //The maximum number of times allowed to =
serve a survey to a user
//triggerParms["rds"]=3D 1; //The minimum number of days to wait to =
serve a survey repeatedly
//triggerParms["mrd"]=3D 1; //The total number of days that a user can =
be re-served a survey
triggerParms["compliant508"] =3D 1; //508 compliant if 1
//DHTML Parameter
triggerParms["dhtml"]=3D 1;// disable dhtml trigger if dhtml=3D0
triggerParms["dhtmlWidth"] =3D 400; // welcome page width
triggerParms["dhtmlHeight"] =3D 290; // welcome page height
triggerParms["dhtmlURL"]=3D "/fsrscripts/FSRInvite.html";
------=_NextPart_000_0000_01C931EC.5A400E00
Content-Type: application/octet-stream
Content-Transfer-Encoding: quoted-printable
Content-Location: http://www.fda.gov/fsrscripts/stdLauncher.js
// Customer:U.S. Food and Drug Administration
// Version : DHTML Trigger 3.0.1
// ************ don't modify below this line *************
var popUpURL =3D "//www.foreseeresults.com/survey/display"; // base URL =
to the survey=20
var FSRImgURL =3D "//www.foreseeresults.com/survey/FSRImg";
var OTCImgURL =3D "//controller.foreseeresults.com/fsrSurvey/OTCImg";
var ckAlreadyShown =3D triggerParms["ascookie"]; // name of the =
persistent/session cookie
var ckLoyaltyCount =3D triggerParms["lfcookie"]; // name of the loyalty =
count cookie
var fullURL=3Dnull;
var oldURL=3Dnull;
var myPopUp=3Dnull;
var fsr_aol=3Dnull;
var dcQString=3D"";
var cpp_3 =3D "";
var winOptions =3D "width=3D 1,height=3D 1,top=3D 4000,left=3D =
4000,resizable=3Dyes,scrollbars=3Dyes";
var persistentExpires =3D new Date(); //persistent cookie expiration=20
persistentExpires.setTime(persistentExpires.getTime() + =
(triggerParms["rw"]*60*1000));
function ForeCStdGetCookie (name) {
var arg =3D name + "=3D";
var alen =3D arg.length;
var clen =3D document.cookie.length;
var i =3D 0;
while (i < clen) {
var j =3D i + alen;
if (document.cookie.substring(i, j) =3D=3D arg) {
return ForeCStdGetCookieVal (j);
}
i =3D document.cookie.indexOf(" ", i) + 1;
if (i =3D=3D 0) {
break;
}
}
return null;
}
function fsr_showWindow() { =20
if(myPopUp !=3D null && !myPopUp.closed && fsr_aol=3D=3Dfalse) =
{return;} =20
var cpp3Str =3D "";=20
cpp_3 =3D "Browser:"+ cppUrlPatch (navigator.userAgent)=20
cpp_3+=3D";dhtml";=09
var pos1 =3D fullURL.indexOf("&cpp_3=3D");
var pos2 =3D fullURL.indexOf("&",pos1+1);
if (pos2=3D=3D-1){
fullURL =3D fullURL.substring(0,pos1);
}else{
cpp3Str =3D fullURL.substring(pos2,fullURL.length);
fullURL =3D fullURL.substring(0,pos1);
} =20
fullURL+=3D"&cpp_3=3D"+cpp_3 + cpp3Str;
=20
if(document.all && document.all.fsr_window.filters) {
eval("document.all.fsr_window").filters.revealTrans.transition =3D 23 =
;
eval("document.all.fsr_window").filters.revealTrans.Apply();
eval("document.all.fsr_window").style.visibility =3D 'visible';
eval("document.all.fsr_window").filters.revealTrans.Play();
}
else if(document.all) {document.all.fsr_window.style.visibility =3D =
'visible';}=09
else if(document.getElementById) =
{document.getElementById("fsr_window").style.visibility =3D 'visible';}=09
}
function fsr_hideWindow() {
if(document.all && document.all.fsr_window.filters) {
eval("document.all.fsr_window").filters.revealTrans.transition =3D 23;
eval("document.all.fsr_window").filters.revealTrans.Apply();
eval("document.all.fsr_window").style.visibility =3D 'hidden';
eval("document.all.fsr_window").filters.revealTrans.Play();
}
else if(document.all) {document.all.fsr_window.style.visibility =3D =
'hidden';}=09
else if(document.getElementById) =
{document.getElementById("fsr_window").style.visibility =3D 'hidden';}
}
function ForeCStdSetCookie (name, value) {
var argv =3D ForeCStdSetCookie.arguments;
var argc =3D ForeCStdSetCookie.arguments.length;
var expires =3D (argc > 2) ? argv[2] : null;
var path =3D (argc > 3) ? argv[3] : null;
var domain =3D (argc > 4) ? argv[4] : null;
var secure =3D (argc > 5) ? argv[5] : false;
document.cookie =3D name + "=3D" + escape (value) +
((expires =3D=3D null) ? "" : ("; expires=3D" + expires.toGMTString())) =
+
((path =3D=3D null) ? "" : ("; path=3D" + path)) +
((domain =3D=3D null) ? "" : ("; domain=3D" + domain)) +
((secure =3D=3D true) ? "; secure" : "");
}
function ForeCStdGetCookieVal(offset) {
var endstr =3D document.cookie.indexOf (";", offset);
if (endstr =3D=3D -1) {
endstr =3D document.cookie.length;
}
return unescape(document.cookie.substring(offset, endstr));
}
function specialEscape(str) {
var translated =3D "";
var i;=20
var found =3D 0;
for(i =3D 0; (found =3D str.indexOf('+', found)) !=3D -1; ) {
translated +=3D str.substring(i, found) + "%2B";
i =3D found + 1;
found++;
}
translated +=3D str.substring(i, str.length);
return translated;
}
function Pop(){
myPopUp =3D window.open(fullURL, 'survey',winOptions);
if ( myPopUp!=3Dnull && !myPopUp.closed) {
if (triggerParms["pu"] =3D=3D 1){
self.focus();
} else {
myPopUp.focus(); =09
}
}
}
function checkMAC(){
if(navigator.platform.indexOf("Win32") >=3D 0){
return false;
} else {
return true;
}=09
}
var detect =3D navigator.userAgent.toLowerCase();
function checkAOL(){
if (detect.indexOf("aol") >=3D0){ return true; }
return false;
}
function currentLocationExcluded() {=09
var parentURLPath =3D window.location.pathname;//location path
for(key in excludeList) {
if(parentURLPath.indexOf(excludeList[key]) !=3D -1) {
return true;
}
}
return false;
}
var newDt;
var currTime; // in millisecs
var OTCImg;
var FSRImg;
var surveyProcessCont =3D 1;
function stdImgProc() {
if(triggerParms["compliant508"] =3D=3D 1) { fsr_showWindow();}
else { setTimeout ( "fsr_showWindow();", 1000, "JavaScript" ); }
}
function fsrShowSurvey(){
if(dcQString =3D=3D "") { stdImgProc(); }
else {
newDt =3D new Date();
currTime=3D newDt.getTime(); // in millisecs
FSRImg =3D new Image();
FSRImg.src =3D null;
FSRImg.onerror =3D imgErrorProc;
FSRImg.onload =3D imgOnloadProc;
FSRImg.src =3D FSRImgURL + "?" + dcQString + "&uid=3D"+ currTime; =
//for NE/FF Cache Fix
}
}
function imgOnloadProc() {
if(surveyProcessCont =3D=3D 1 && FSRImg.width =3D=3D 3) { stdImgProc(); =
}
return true;
}
function imgErrorProc() {
surveyProcessCont =3D 0;
return true;
}
function otcOnloadProc() { =20
if(surveyProcessCont =3D=3D 1 && OTCImg.width =3D=3D 3) { =
fsrShowSurvey(); }
else { surveyProcessCont =3D 0; }
return true;
}
function otcErrorProc() {
fsrShowSurvey();
return true;
}
function Poll() {=20
if(triggerParms["dt"] =3D=3D 1) {
return;
}
if(currentLocationExcluded()) {
return;
}
var stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount); // check =
counter cookie
var alreadyShown =3D ForeCStdGetCookie(ckAlreadyShown); // check if we =
already have shown survey
var pageCount;
var randNum =3D Math.random();
randNum *=3D 100;
if (stickyCounter =3D=3D null) {
pageCount =3D 1;=20
ForeCStdSetCookie(ckLoyaltyCount, pageCount, =
null,'/',triggerParms["domain"]);
stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount);
}
if (stickyCounter !=3D null) {
pageCount =3D stickyCounter;
if(pageCount >=3D triggerParms["lf"]) {
if(alreadyShown =3D=3D null) {
if (triggerParms["rso"] =3D=3D 1 && triggerParms["aro"] =3D=3D 1) {
triggerParms["sp"] =3D 100.0; // Update Ssample percentage
}
if(randNum <=3D triggerParms["sp"]) {
fsr_aol=3D checkAOL();
var fsr_mac=3D checkMAC(); =09
var fsr_browser=3D"fsr_nn6";
if(document.all || document.getElementById){=20
fsr_browser =3D "fsr_ie";
}
if(document.layers) {
fsr_browser =3D "fsr_nn";
}
fullURL =3D popUpURL + "?" + "width=3D" + triggerParms["width"] +
"&height=3D" + triggerParms["height"] +
"&cid=3D" + specialEscape(escape(triggerParms["cid"])) + "&mid=3D" =
+ specialEscape(escape(triggerParms["mid"]));
if ((triggerParms["omb"] ) !=3D null) {
fullURL +=3D "&omb=3D" + escape(triggerParms["omb"]);
}
if ((triggerParms["cmetrics"] ) !=3D null) {
fullURL +=3D "&cmetrics=3D" + escape(triggerParms["cmetrics"]);
}
if (triggerParms["olpu"] =3D=3D 1) {
fullURL +=3D "&olpu=3D1";
}
if ((triggerParms["dcUniqueId"]) !=3D null) {
fullURL +=3D "&dcUniqueId=3D" + =
escape(triggerParms["dcUniqueId"]);
}
if (triggerParms["rso"] =3D=3D 1) {
fullURL +=3D "&rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" + =
triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + =
triggerParms["rw"];
}
if (triggerParms["capturePageView"] =3D=3D 1) {
triggerParms["cpp_2"] =3D "PageView:"+ pageCount; // customer =
parameter 2 - Page View
}
if ((triggerParms["midexp"] ) !=3D null) {
fullURL +=3D "&ndc=3D1&fsexp=3D5256000&midexp=3D" + =
triggerParms["midexp"];
}
triggerParms["cpp_3"] =3D "Browser:"+ cppUrlPatch =
(navigator.userAgent) + ";normal"; =09
var customerParams =3D "";
=09
for(paramKey in triggerParms) {
if(paramKey.substring(0,3) =3D=3D "cpp"){
fullURL +=3D "&" + paramKey + "=3D" + =
escape(triggerParms[paramKey]);
}
}=09
oldURL=3DfullURL;
if (triggerParms["rso"] !=3D 1) {
if(triggerParms["npc"] =3D=3D 1) {
ForeCStdSetCookie(ckAlreadyShown, =
'true',null,'/',triggerParms["domain"]);
} else {
ForeCStdSetCookie(ckAlreadyShown, 'true', =
persistentExpires,'/',triggerParms["domain"]);
}
}
// for AOL users - show DHTML (by default)
if (fsr_aol=3D=3Dfalse) {
myPopUp =3D window.open(fullURL, 'survey',winOptions);
}
if (fsr_mac=3D=3Dfalse && (fsr_browser !=3D "fsr_nn") && =
(triggerParms["dhtml"] =3D=3D 1)) {
fullURL=3DoldURL;
fsr_left =3D (screen.width - triggerParms["dhtmlWidth"])/2;
fsr_top =3D Math.min((screen.height - =
triggerParms["dhtmlHeight"])/2,150);
=09
document.write(""
+ "
");
=09
//DC I/II verification
if (triggerParms["rso"] =3D=3D 1) {
dcQString =3D "rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" =
+ triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + =
triggerParms["rw"];
if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D =
"&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); }
}
if ((triggerParms["midexp"] ) !=3D null) {
dcQString =3D "ndc=3D1&midexp=3D" + triggerParms["midexp"] + =
"&mid=3D" + specialEscape(escape(triggerParms["mid"]));
if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D =
"&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); }
} =09
=09
//Failover Check
surveyProcessCont =3D 1; =09
newDt =3D new Date();
currTime=3D newDt.getTime(); // in millisecs
OTCImg =3D new Image();
OTCImg.src =3D null;
OTCImg.onerror =3D otcErrorProc;
OTCImg.onload =3D otcOnloadProc;
OTCImg.src =3D OTCImgURL + "?protocol=3D" + =
window.location.protocol + "&uid=3D"+ currTime; //for NE/FF Cache Fix
} =09
if(myPopUp !=3D null && !myPopUp.closed) {
if (triggerParms["pu"] =3D=3D 1){ self.focus(); }
else { myPopUp.focus(); }
}
}
}
} =09
pageCount++;
ForeCStdSetCookie(ckLoyaltyCount, pageCount, =
null,'/',triggerParms["domain"]); =09
}
}
------=_NextPart_000_0000_01C931EC.5A400E00--
![3D"FDA](3D"http://www.fda.gov/graphics/mastheadart/images/fda_mast_01.gif"=20)
![3D""=20](3D"http://www.fda.gov/graphics/mastheadart/images/fda_mast_bkgrd.gif"=)
![3D"U.S.](3D"http://www.fda.gov/graphics/mastheadart/images/fda_mast_02.gif"=20)
![3D"HHS](3D"http://www.fda.gov/graphics/mastheadart/images/fda_mast_03.gif"=20)