A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
ICH’s Guidelines Helped Bring NDMA Contamination Problem to Light: NIHS Officials
Voluntary recalls have continued over the last year following the detection of the carcinogen N-nitrosodimethylamine or NDMA in a number of drugs. These problems were likely to be found by the introduction of the International Council for Harmonization’s (ICH) guidelines…
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