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638 result(s) found, displaying 176 to 200
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4C; EMA/CHMP/ICH/308867/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4B; EMA/CHMP/ICH/308817/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4A; EMA/CHMP/ICH/308671/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 3; EMA/CHMP/ICH/561176/2007
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 13; CHMP/ICH/405290/2010
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Considerations for the inclusion of adolescent patients in adult oncology clinical trials - guidance for Industry.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Submitting documents using real world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics.
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International scientific guidelines adopted in AustraliaThe general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Use of electronic health record data in clinical investigations – Guidance for industry.
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User guideThe system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 11; CHMP/ICH/730028/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 12; CHMP/ICH/730808/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 1; EMA/CHMP/ICH/222063/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 10; EMA/CHMP/ICH/381133/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q10; EMA/CHMP/ICH/214732/2007
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q8, Q9 & Q10 Q&As (volume 4); EMA/CHMP/ICH/265145/2009
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.
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FormsUse this form to make a freedom of information (FOI) request for a document held by the Therapeutic Goods Administration (TGA).
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
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User guideUsing the ADR reporting template in the Medical Director software
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/608924/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M2(R2); EMA/CPMP/ICH/286/1995