Wonder why the drug companies are going overseas for drug studies, no one is watching!

[Guest guest]

CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT

FOREIGN CLINICAL TRIALS

http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf

The FDA should take measures to ensure clinical investigators

disclose all financial interests and improve monitoring of foreign

trials, according to the HHS Office of Inspector General (OIG).

Although sponsors are required to collect financial information on

all clinical investigators before trials begin, they are not

required to give that information to the FDA until they submit

marketing applications after trials have already ended, OIG writes

in a March update of its “Compendium of Unimplemented

Recommendations.”

[Guest guest]

CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT

FOREIGN CLINICAL TRIALS

http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf

The FDA should take measures to ensure clinical investigators

disclose all financial interests and improve monitoring of foreign

trials, according to the HHS Office of Inspector General (OIG).

Although sponsors are required to collect financial information on

all clinical investigators before trials begin, they are not

required to give that information to the FDA until they submit

marketing applications after trials have already ended, OIG writes

in a March update of its “Compendium of Unimplemented

Recommendations.”

[Guest guest]

CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT

FOREIGN CLINICAL TRIALS

http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf

The FDA should take measures to ensure clinical investigators

disclose all financial interests and improve monitoring of foreign

trials, according to the HHS Office of Inspector General (OIG).

Although sponsors are required to collect financial information on

all clinical investigators before trials begin, they are not

required to give that information to the FDA until they submit

marketing applications after trials have already ended, OIG writes

in a March update of its “Compendium of Unimplemented

Recommendations.”

[Guest guest]

CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT

FOREIGN CLINICAL TRIALS

http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf

The FDA should take measures to ensure clinical investigators

disclose all financial interests and improve monitoring of foreign

trials, according to the HHS Office of Inspector General (OIG).

Although sponsors are required to collect financial information on

all clinical investigators before trials begin, they are not

required to give that information to the FDA until they submit

marketing applications after trials have already ended, OIG writes

in a March update of its “Compendium of Unimplemented

Recommendations.”