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Date Posted
News Title
2024/03/13
US: Experts discuss how to avoid STeP, breakthrough device submission missteps
2024/03/12
Europe: European Commission proposes framework for joint clinical assessments
2024/03/11
US: FDA recommends participants receive key trial information early, concisely
2024/03/08
Asia: CDSCO seeks feedback on biological postapproval change guidance
2024/03/07
Europe: UK MHRA grants first approval via the new International Recognition Procedure in 30 days
2024/03/06
US: Generic group says FDA’s ophthalmic guideline should align with ICH Q3B(R2)
2024/03/05
Europe: EMA seeks feedback on planned COVID antiviral, antibody guidance
2024/03/04
US: FDA finalizes guidance on designing pharmacology studies for antibody-drug conjugates
2024/03/01
US: FDA proposes waiving device registration fees for firms making less than $1M, in bankruptcy
2024/02/28
Asia: Australia’s TGA joins with international peers to coordinate GMP inspections globally
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