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Bayer Receives Warning Letter for Alleged Deviations
September 24th 2009The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).
Senate Finance Committee Introduces Latest Legislative Proposal for Healthcare Reform
September 17th 2009The Senate Finance Committee through its chairman, Max Baucus (D-MT), introduced on Sept. 16, 2009, a bill, "America's Healthy Future Act of 2009," representing the latest Congressional proposal for healthcare reform.
FDA's Sharfstein Outlines Principles of Public Health Agency
September 17th 2009Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency.
The Advantages of Small-Format Equipment: A Q&A with Scott C. Garverick
September 16th 2009Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market.
EMEA mandates electronic submissions by 1 January 2010
September 11th 2009The European Medicines Agency (EMEA) has issued a reminder that the Electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from 1 January 2010.
Controlled-Release Formulations a Popular Strategy for Generic-Drug Companies
September 10th 2009Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.
WITNESS software leads to success for Sanofi
September 4th 2009Sanofi aventis has finished implementing Lanner's process simulation software into one of its major UK sites following a successful Phase I implementation in which the company made more than £1 million in inventory cost savings in 6 months.
FDA Issues Final Guidance on OTC Drug Labeling
September 3rd 2009The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.