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Top Stories
The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.
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Tina Morris will be taking on the role of executive director for AAPS.
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Industry News
Fios Genomics, a spin-out bioinformatics company from Edinburgh University, has entered into a strategic partnership with Charles River Laboratories.
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The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Supplier News
Drug development contract services company PPD announces initial public offering.
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Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.
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Bio/Pharma News
As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
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The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.
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Regulatory News
The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
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The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
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The Digital Path to Pharma Quality Management
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Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
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FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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