Simplifying Global Compliance
Articles Tagged with ''FDA''
The FDA issued a guidance classifying computerized labor monitoring systems into Class II and providing recommendations to manufacturers submitting 510(k)s for these devices. Read More
Development of unique device identification (UDI), similar to the bar codes on drugs and biologics, could vastly improve the FDA's ability to respond to adverse events and track recalls, Jeff Crowley, the FDA's senior adviser for patient safety, said. Read More
Clark Research and Development failed to validate sterilization studies for its biocompatible hemoperfusion cartridges, according to an FDA warning letter. Read More
Roche's pending applications for investigational erythropoiesis-stimulating agent (ESA) Mircera in the U.S. and Europe are proceeding according to plan, William Burns, CEO of Roche's pharma division, said. Read More
The FDA issued a guidance classifying computerized labor monitoring systems as Class II, or special controls. Read More
Wyeth received an approvable letter from the FDA for its postmenopausal osteoporosis prevention product, bazedoxifene, April 24. Bazedoxifene's brand name, Viviant, is still under FDA review. Read More
The FDA approved Bell-More Laboratories to manufacture sterile pharmaceutical products after the company corrected several issues noted in an agency warning letter. Read More
Alcon Laboratories' retail sell sheet and sales aid for its antibiotic Ciprodex omit material facts, including important risk information and limitations, according to a warning letter from the FDA. Read More
The FDA issued a public health advisory last month warning physicians that use of erythropoiesis-stimulating agents (ESAs) is associated with an increased risk of death and serious life-threatening side effects. Read More
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