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IST Measures Raise Concern for the Pharma Supply Chain
March 5th 2008Draft federal legislation that would require high-risk chemical facilities to use inherently safer technology for reducing their risk may present potential problems for custom and batch manufacturers supplying the pharmaceutical industry.
Merck Invests $1.5 Million in TEM Imaging Service Laboratory
February 28th 2008Merck Capital Ventures, a subsidiary of Merck & Co., has invested $1.5 million to expand its service laboratory. The transaction with NanoImaging Services will add high-resolution, three-dimensional transmission electron microscope (TEM) capability, which allows biopharmaceutical researchers to see complex macromolecular structures they create with resolution as high as one nanometer.
Vintage Pharmaceuticals Receives Warning Letter
February 21st 2008The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.
Symposium Marks the Launch of the European Human Embryonic Stem Cell Registry
February 21st 2008Last month, the European Human Embryonic Stem Cell Registry became operational. The organization hosted the 1st European Human Embryonic Stem Cell Registry Symposium to coincide with the launch of the program.
FDA to Allow Off-Label Information
February 21st 2008The US Food and Drug Administration issued a draft guidance for industry titled "Good Reprint Practices" regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
Baxter Voluntarily Recalls Heparin Lots
February 14th 2008Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.