...fell to a new low in FY 2005, with only 18 sent out worldwide. Oral solid manufacturers were not among the variety of operations targeted. A recurrent theme was inadequate contamination control, with two thirds of the letters addressing related problems. One third encompassed cGMP and NDA/monograph concerns. The warning letters provide detailed commentary on the firms’ responses to the inspection findings as well as on the FDA-483 observations themselves. As such, they shed important light on FDA compliance policy for the various types of operations addressed and on the expectations for corrective action. [The drug and therapeutic biologic cGMP warning letters issued in FY 2005 are listed. The listing is organized according to the type of facility involved, and includes the recipient’s name, letter date, plant location and a description of the problem areas cited.]
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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