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- Shortages and supply disruptions (23)
- Safety monitoring and information (11)
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Collection content
116 result(s) found, displaying 41 to 50
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PageEvaluation plan estimators to approximate dates of milestones in the prescription medicine registration process.
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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).
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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FormsForms for notifying the TGA of a change in sponsorship.
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Medicine shortage alertsSerious Scarcity Substitution Instrument (SSSI) allows continuous access to Catapres (clonidine) 150 mcg tablets during an anticipated new shortage.
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PageUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver.