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Benefits of Structured Content in Preparing Data for Regulatory SubmissionsHow taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information
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How Do Drug Shortages Affect Pharmacovigilance?Drug shortages, including critical antibiotics, fever medications, and cancer treatments, highlight global supply chain issues and the need for improved health policies to prevent medication bottlenecks.
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The Evolving Value Assessment Landscape in the USHow current frameworks influence coverage decisions and pricing negotiations.
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Understanding the FDA's Exemption for DSCSA ComplianceIn the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
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DSCSA 2024 or 2023 Déjà Vu?A look at the challenges that need to be addressed during the FDA stabilization period.
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Challenges in Cell and Gene Therapy Manufacturing, Sterility AssuranceManufacturers should leverage the knowledge base of personnel working in sterility assurance and in microbiology laboratories.
