TGA Seeks Input: Adoption of International Scientific G…
The Therapeutic Goods Administration (TGA) Australia is actively seeking public input on the adoption of thirteen international scientific g…
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Thai FDA’s Proposed Draft Notification: Annual Sa…
Thai FDA proposes a draft Notification mandating annual safety reports for terminated or completed clinical research, aligning with Herbal P…
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FDA Guidance on Developing Chimeric Antigen Receptor (C…
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products. Focused on s…
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US FDA Eases Informed Consent for Minimal Risk Clinical…
FDA Implements 21st Century Cures Act: Effective 30 days post-publication, ensuring rights and safety of human subjects. The final rule amen…
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FDA Proposes Human Abuse Potential Study for Kratom
FDA allocates $2 million for institutions conducting a Human Abuse Potential (HAP) study on botanical Kratom due to rising concerns over its…
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Australia: TGA Repeals Advertising Permission for Nicot…
The Therapeutic Goods Administration (TGA) has repealed the Advertising Permission for Nicotine, effective from 1 January 2024. This move co…
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Increased Risk of Neurodevelopmental Disorders in Child…
New research indicates a higher risk of neurodevelopmental disorders in children when fathers took valproate three months before conception.…
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ANVISA adopts new flows to request for consent to impor…
ANVISA (Brazil) Introduces Streamlined Processes for Importing Experimental Medicines: New procedures exclude pre-boarding inspections for d…
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NPRA published Guidance Document and Guidelines for Reg…
The NPRA has released a revised edition of the biosimilar product registration guidelines in the second edition of the Guidance Document and…
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HSA Singapore: 4 Products Found to Contain Potent or Ba…
Health Sciences Authority (HSA) of Singapore has issued a public alert regarding four products sold online that were found to contain potent…
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