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HSA Singapore Updates Guidelines on Manufacturing Stand…
In September 2024, the Singapore Health Sciences Authority (HSA) released revised guidelines concerning manufacturing standards for Health S…
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Conducting Clinical Trials With Decentralized Elements
The FDA has issued final Level 1 guidance (Docket Number: FDA-2022-D-2870) from the Center for Drug Evaluation and Research, the Center for …
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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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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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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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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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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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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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