Keyword Analysis & Research: pmda


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What does PMDA mean?

The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in Japan in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The current PMDA was established in 2004 by incorporating the Pharmaceuticals and Medical Devices Evaluation Center of the ...

What is the pharmaceuticals and Medical Devices Agency?

The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in Japan in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects.

Does the PMDA share information with the USFDA?

The PMDA understands that this non-public information is shared in confidence, and that the USFDA considers it critical that the PMDA maintain the confidentiality of the information. Public disclosure of this information by the PMDA could seriously jeopardize any further scientific and regulatory interactions between the USFDA and PMDA.

What happens if the PMDA shares information that is not public?

Public disclosure of this information by the PMDA could seriously jeopardize any further scientific and regulatory interactions between the USFDA and PMDA. The US FDA will advise the PMDA of the non-public status of the information at the time that the information is shared.

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