US: FDA developing guidance on real-world data quality issues

(Source: RAPS 2019-09-13)

As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations.


China: CDE moves to improve communication with drug developers

(Source: RAPS 2019-09-12)

China’s Center for Drug Evaluation (CDE) has outlined a series of measures intended to improve its communication with biopharma companies. The changes include the introduction of times when CDE officials are available for face-to-face interactions with drug developers.


Taiwan: TFDA host “2019 International Conference on Narcotics: Safe Use and Management”

(Source: TFDA 2019-09-11)

In order to keep narcotics regulations up-to-date with international practice and to prevent narcotic misuse or abuse leading to addiction, Taiwan Food and Drug Administration of the Ministry of Health and Welfare organizes the “2019 International Conference on Narcotics: Safe Use and Management” on 4 September. The conference will take place at NTUH International Convention Center. Officials and experts from Europe, the U.S., Japan, and Thailand have been invited to the event, to exchange insights on their management of narcotics and prevention of iatrogenic addiction with Taiwan’s government officials, scholars and experts.

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