AER Label Guidance Holds To Requiring Full Addresses For OTCs, Supplements
FDA is extending the deadline for serious adverse event labeling requirements for OTC drugs and dietary supplements until January 2010 because it has yet to finalize its guidance to comply with those regulations
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Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.
Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.
European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.