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Oct 22 min read

UK MHRA Guidance: Pre-submission Advice & Support

UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...

Aug 152 min read

UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...

Dec 2, 20221 min read

USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug

Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...