Top Stories
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
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The company broke ground on a R&D and process development facility in Missouri.
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Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Industry News
An NIH study examined a dissolving microneedle technology as a way to deliver the influenza vaccine to patients.
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The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
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Supplier News
Krinsky joined the board of directors at Halo after working for Teva Pharmaceuticals for 12 years.
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The Own It Now channel allows buyers to view scheduled price decreases for used equipment and make purchases online.
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Bio/Pharma News
Two recently-signed agreements will transfer Takeda's measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.
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The patent was filed for a chewing gum composition with controlled release of cannabinoids and opioid agonists, and antagonists for addiction or dependence treatment.
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Regulatory News
The agency announced a plan to eliminate its existing orphan designation request backlog.
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The agency determined additional guidance was needed to reduce regulatory compliance burden.
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SUPPLY CHAIN
The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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QUALITY
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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July 13–14, 2017
August 15–16, 2017
August 16–17, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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