Featured Pharma Online Editorial
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PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
4/24/2025
Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
4/17/2025
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting
4/16/2025
Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.
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Pharmaceutical Sovereignty: The Resilience We Cannot Outsource
4/15/2025
Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration.
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4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs
3/6/2025
Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.
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The Rise Of AI-Powered Drones In Clinical Logistics And Supply Chains
3/5/2025
Drone technology has significantly advanced, benefiting from improved connectivity, GPS accuracy, and AI/ML.
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Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data
1/23/2025
The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.
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Will FDA Finally Enforce DSCSA Interoperability In 2025?
12/26/2024
Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.
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Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.