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Combination Products cGMP Compliance
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Saudi FDA Releases Guidance on Registering Clinical Trials
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Two More Tropical Diseases Eligible for Priority Review Voucher in U.S.
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India Approves $270 Million Plan to Upgrade Drug Regulations
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U.S. Industry Seeks Clarity on CMC Draft Guidance
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Viral Shedding Studies Focus of U.S. FDA Final Guidance
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U.S. FDA’s Authority to Enforce Quality Metrics Questioned
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EMA Adverse Event Monitoring Service Now Fully Operational
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EU Updates Postauthorization Safety Studies Guideline
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European Regulators Seek Input on Updated GCP Guidance
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U.S. FDA Proposes Naming Convention for Biosimilars, Reference Products
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China Outlines Plan to Encourage Innovation, Speed Drug Approvals
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