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Top Stories
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.
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Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
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Industry News
The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.
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CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.
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Supplier News
Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals.
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The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.
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Bio/Pharma News
The divestiture of the European generic-drug business of Sanofi–Zentiva–to Advent International has been completed.
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The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.
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Regulatory News
As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK's exit from the European Union on the Pharma sector.
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The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
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SUPPLY CHAIN
As counterfeiting, API manufacturing issues, and illegal diversion increase vulnerability, could dispensers and even patients play a greater role in securing the pharma supply chain?
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MANUFACTURING
While food, shelter, and clothing are the primal essentials for life, hope–as embodied by modern medicine–has now become part of that human expectation.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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EXCIPIENTS
Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
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UPCOMING WEBCASTS
Insoluble APIs Scaring You?
Don't be Afraid of Nanoparticles!
Wednesday, October 31, 2018 at 11am EDT|8am PDT|3pm GMT|4pm CET
 Register now
Sterility Testing: Best Practices and Use of Isolator Technology
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Successfully Navigating the Analytical Environment of Complex Generic APIs
Tuesday, October 16, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
 Register now
Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
Europe: Thursday, October 11, 2018 at 2pm BST/ 3pm CEST
North America: Thursday, October 11, 2018 at 11am EDT/ 8am PDT/ 10am CDT
 Register now
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Events
October 9–11, 2018
October 9–11, 2018
October 14–17, 2018
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eBOOKS
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This ebook covers 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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