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.

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.

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

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

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.

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

Has the long-awaited guidance answered all of the industry's questions?

Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference.