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The Therapeutic Goods Administration (TGA) has repealed the Advertising Permission for Nicotine, effective from 1 January 2024.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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Seizure Of Over $2 Million Worth Of Illegal Medicine Im…
In a joint effort, the Therapeutic Goods Administration (TGA) and Australian Border Force (ABF) successfully seized over $2 million worth of…
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US FDA Releases Draft Guidance on Translation for Good …
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that t…
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ANVISA updated procedures for imports of medicines incl…
ANVISA has updated its import authorization procedures for medicines and substances subject to special control. It is worth remembering that…
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