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Combination Product Rules Clear OMB, To Be Released In Weeks

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's general idea is for companies to choose one operating system, drug or device, then tack on procedures certain components require, not follow different rules for different components, agency expert says at RAPS.

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Regulatory News In Brief

Abbott catheter recall: Abbott is recalling four lots of Powersail coronary dilation catheters--three from U.S. distribution and one from international distribution--following four complaints of damage to the distal shaft of the catheter, firm announced July 28. FDA is classifying the recall as Class I, the most serious category, according to the firm. The observed damage could cause the contrast material to leak, potentially causing clinical problems such as air embolism or myocardial infarction, Abbott says. Sales reps have instructed all customers to stop using the affected lots. Patients already successfully treated with Powersail coronary catheters are not affected by the recall

Combo Product Firms Lose Patience As Regs, Guidance Are Delayed Again

Combination product companies want the next FDA commissioner to raise the profile of combo product issues within the agency

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.





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