Portuguese Industry Opposes U.S. Proposal for Cancer Wa…
The United States Health Authority is considering the introduction of mandatory cancer warning labels on alcoholic beverages, a measure simi…
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US FDA Announces Draft Guidance on AI Use in Regulatory…
On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled “Considerations for the U…
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US FDA Announces Public Meeting on Paediatric Legislati…
The Food and Drug Administration (FDA) has scheduled a public meeting titled “Interested Parties Meeting: Implementation of the Best Pharm…
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FDA (USA) Establishes New Center for Real-World Evidenc…
On December 12, 2024, the U.S. Food and Drug Administration (FDA) announced the creation of the Center for Real-World Evidence and Innovatio…
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DINAVISA (Paraguay) Approves New Guideline for Good Eva…
On December 2, 2024, the National Directorate of Sanitary Surveillance (DINAVISA) introduced the “Guide to Good Evaluation Practices f…
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AGEMED (Bolivia) Opens Public Consultation on Draft Gui…
The Bolivian Agency for Medicines and Health Technologies (AGEMED) announced on November 25, 2024, the launch of a public consultation on it…
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NMPA Approves First Clinical Trial Application Under Pi…
On November 15, 2024, China’s National Medical Products Administration (NMPA) announced a milestone in its pilot program designed to optim…
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ANSM Publishes Comprehensive Overview on Antibiotic Con…
In alignment with World Antimicrobial Resistance Awareness Week, the French National Security Agency of Medicines and Health Products (ANSM)…
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MHLW (Japan) Encourages Use of Real-World Data (RWD) fo…
On October 7, 2024, Japan’s Ministry of Health, Labor, and Welfare (MHLW) issued a significant notification encouraging the use of Real-Wo…
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FDA Issues Proposed Order to Remove Oral Phenylephrine …
The U.S. Food and Drug Administration (FDA) announced today a proposal to eliminate oral phenylephrine as an approved active ingredient in o…
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