Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

Industry Comments on Senate Passage of PDUFA V

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

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.

ICH Q11 Drug Substance Guideline Has Gained Global Approval

May 16, 2012

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.

FDA Issues Final Rule on Sterility Testing of Biologics

May 8, 2012

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.

Some Supply Chain Lessons Can Go a Long Way towards Success

Apple's experience with manufacturing facilities in China present opportunity for future best practice.
May 2, 2012

Apple's experience with manufacturing facilities in China present opportunity for future best practice.

Meeting Manufacturing Challenges Tied to Extended-Release Injectables

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
May 2, 2012

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

Supply Chain Lessons

May 1, 2012

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.

CDER Adds to Online Regulatory Learning Program

Apr 17, 2012

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

McCoy to Leave J&J, Gorsky Prepares to Take Over

Apr 10, 2012

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.

Waters, NIBRT Partner to Grow Knowledge of Large-Molecule Characterization

Mar 29, 2012

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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