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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The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.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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Webinar Alert: B. cepacia complex (Bcc) Testing for Non-Sterile Water-Based Drug Products
Watch Eurofins BioPharma Product Testing’s on-demand webinar on B. cepacia complex (Bcc) testing, the absence of Bcc and FDA’s guidance on prevention and detection. Our expert will also cover the history, health risks, recalls and lessons learned, as well as a glimpse of the USP <60> draft for Bcc testing.
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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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