FDA updates eCTD guidance for human pharmaceutical products | Dr. Vishwas Parab posted on the topic | LinkedIn
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FDA updates eCTD guidance for human pharmaceutical products | Dr. Vishwas Parab posted on the topic | LinkedIn
The FDA has updated its guidance for electronic submissions of human pharmaceutical product applications using the eCTD specifications. Key changes include updated timetables for electronic submissions and clarifications on submission requirements. The guidance is crucial for industry stakeholders to comply with regulatory standards and enhance ...
Sep 22, 2024
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