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99 result(s) found, displaying 31 to 40
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceGuidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).