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Top Stories
Recent studies show that more companies are evaluating or using AI, and that top-down management support is a driving force.
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A July article in Science suggests that FDA enforcement activities have dropped significantly during the current US presidential administration.
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Industry News
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
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Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
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Supplier News
The Bosch packaging machinery business, including the pharma unit, will remain intact in the transfer to private equity firm CVC.
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Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
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Bio/Pharma News
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
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Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
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Regulatory News
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company's Norwalk facility.
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cGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAs
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QUALITY BY DESIGN
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
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GMP COMPLIANCE
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
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REGULATORY
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
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September 10–11, 2019
September 16–18, 2019
September 18–20, 2019
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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