US FDA’s 2024 Advancing Generic Drug Development …
The FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is set to host the highly antic…
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Pharma and Biotech
Thailand FDA Enhances Drug Labeling and PIL Rules: New …
On August 20, 2024, the Food and Drug Administration (FDA) of Thailand issued an important update to the guidelines for electronically submi…
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Pharma and Biotech
EMA Recommends Approval of the First Vaccine to Protect…
On May 31, 2024, the European Medicines Agency (EMA) announced its recommendation for the approval of Ixchiq, the first vaccine designed to …
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Pharma and Biotech
Thailand: Updated Dosage Limits for Drugs Containing Fa…
The Ministry of Public Health in Thailand has unveiled a draft notification outlining updated dosage limits for drugs containing fat-soluble…
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Pharma and Biotech
Proposed changes to the Pharmaceutical Advertising Advi…
Health Canada is currently scrutinizing a significant revamp of pharmaceutical advertising standards proposed by the Pharmaceutical Advertis…
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Pharma and Biotech
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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Pharma and Biotech
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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Pharma and Biotech
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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Pharma and Biotech
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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Pharma and Biotech
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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Pharma and Biotech