Articles by Erik Greb - Pharmaceutical Technology

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Articles by Erik Greb

FDA Publishes Guidance for Preventing Cross-Contamination

Apr 14, 2011

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

J&J Reorganizes Consumer Group

Apr 7, 2011

Johnson & Johnson has instituted a new structure for its Consumer Group according to a Reuters report.

Scrutinizing the Subvisible

Regulators question whether particles that they can't see hurt patients.
Apr 2, 2011

Regulators question whether particles that they can't see hurt patients.

Sanofi Issues Bonds to Fund Genzyme Acquisition

Mar 31, 2011

On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021, and the interest rates range from 0.05% to 4%.

Pfizer Considers Selling Its Businesses

Mar 24, 2011

Pfizer is considering divesting some of its businesses to maximize their value, according to remarks made by Mikael Dolsten, Pfizer's president of worldwide research and development, at a Barclays Capital investor conference last Thursday.

Senate Passes Patent-Reform Bill

Mar 17, 2011

Last Tuesday, the US Senate approved the "America Invents Act," which is intended to reform the nation ’s patent system. If it becomes law, the bill will establish a first-to-file system by defining an invention ’s effective filing date as the actual filing date of the patent or patent application.

FDA Files Consent Decree against Johnson & Johnson

Mar 17, 2011

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

The Rise of In-Line Blending

Mar 16, 2011

Growing interest in continuous drug manufacturing has brought greater attention to in-line blending, a process that the petroleum and fine-chemicals industries have used for decades.

Consent Decree (Finally) for J&J

Mar 14, 2011

FDA and J&J signed a consent decree of permanent injunction that prevents the company from manufacturing or shipping drugs from its Fort Washington facility until it complies with current good manufacturing practice requirements.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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