FDA to strengthen safety review procedures for marketed drugs
SCRIP - World Pharmaceutical News, Date published: 08 November 2004, p. 12. After its safety review procedures in two recent, well publicised cases were widely criticised as inadequate, the US FDA has announced that it is taking steps to improve them. It is contracting for an independent study by the Institute of Medicine (IOM), creating a formal system for resolving internal scientific disputes, and conducting a national search for a director of the Center for Drug Evaluation and Research's Office of Drug Safety.
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2004.11.12
pdf - 21k |
FDA to strengthen safety review procedures for marketed drugsSCRIP - World Pharmaceutical News, Date published: 08 November 2004, p. 12. After its safety review procedures in two recent, well publicised cases were widely criticised as inadequate, the US FDA has announced that it is taking steps to improve them. It is contracting for an independent study by the Institute of Medicine (IOM), creating a formal system for resolving internal scientific disputes, and conducting a national search for a director of the Center for Drug Evaluation and Research's Office of Drug Safety.
A level playing field: A Biochimica Opus Story
Guy Villax, CEO of Hovione, calls on the European authorities to inspect API producers abroad. An account of the FDA’s investigation of Roussel and Opos showed that some ingredients for Cefaclor manufacture came from unapproved sources, that false records were kept to hide fraudulent activity, that Cefaclor and two other antibiotics were not being made according to the original drug applications, that critical manufacturing steps for these antibiotics were being done secretly in other facilities and that unapproved facilities in France, Italy and Romania were being used in the manufacture of Cefaclor.
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2005.07.27
pdf - 22k |
FDA to strengthen safety review procedures for marketed drugsSCRIP - World Pharmaceutical News, Date published: 08 November 2004, p. 12. After its safety review procedures in two recent, well publicised cases were widely criticised as inadequate, the US FDA has announced that it is taking steps to improve them. It is contracting for an independent study by the Institute of Medicine (IOM), creating a formal system for resolving internal scientific disputes, and conducting a national search for a director of the Center for Drug Evaluation and Research's Office of Drug Safety.
