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USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

Aug 19
2 min

USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)

Aug 18
2 min

UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)

The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...

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

Aug 15
2 min

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...

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