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Collection content
116 result(s) found, displaying 71 to 80
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PageHow to submit nonclinical studies in Module 4 of the Common Technical Document (CTD).
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GuidanceGuidance providing an overview of the Common Technical Document (CTD), modules 1-5. The CTD is a set of dossier specifications for the registration of medicines.
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PageInformation on special considerations required for medicines for use in special populations.
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GuidanceGuidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma.
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PageInformation about progressive discontinuation of Benpen injection products
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Medicine shortage alertsInformation about the cyclophosphamide and ifosfamide injection shortages.
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Medicine shortage alertsThe overall supply of methylphenidate modified-release products continues to improve and stabilise.
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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User guideInformation on how to compile a literature based submission (including mixed applications).
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Medicine shortage alertsWe have extended the SSSI in response to the ongoing shortage