The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.
May 29, 2012
By:
Angie Drakulich
The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.
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May 16, 2012
By:
Angie Drakulich
ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.
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May 8, 2012
By:
Angie Drakulich
FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.
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Apple's experience with manufacturing facilities in China present opportunity for future best practice.
May 2, 2012
By:
Angie Drakulich
Apple's experience with manufacturing facilities in China present opportunity for future best practice.
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Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
May 2, 2012
By:
Angie Drakulich
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
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May 1, 2012
By:
Angie Drakulich
Once again, Apple is doing something the rest of the world should be paying attention to, only this time it's about the company's approach to managing the global supply chain—even when things go wrong.
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Apr 17, 2012
By:
Angie Drakulich
This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.
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Apr 10, 2012
By:
Angie Drakulich
Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position.
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Mar 29, 2012
By:
Angie Drakulich
The National Institute for Bioprocessing Research and Training in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge.
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