Articles by Angie Drakulich - BioPharm International

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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 18, 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 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

No matter the time or cost, knowing what's going on inside your facilities is always going to be worth the effort.
May 1, 2012

No matter the time or cost, knowing what's going on inside your facilities is always going to be worth the effort.

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

Apr 17, 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, being filled by Alex Gorsky.

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.

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

Apr 3, 2012

The National Institute for Bioprocessing Research and Training (NIBRT) in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge, according to an NIBRT press release.

FDA Issues Guidance Agenda for 2012

Mar 13, 2012

FDA has issued a list of planned draft and final guidance documents for release throughout 2012.

Meeting Challenges in Contract R&D

Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.
Mar 2, 2012

Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.

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