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MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
The number of technology and life sciences companies going public increased 62 percent in 2013, showing a “very strong” IPO market that took off in the second quarter, according to a survey by law firm Fenwick & West. Read More
Sponsors of new medical technologies must include a description of any pediatric subpopulations that suffer from the condition the product is intended to treat. Read More
Northwestern University has provided information to a Senate panel investigating a clinical trial conducted there several years ago, but the senator behind the inquiry says the school is far from in the clear. Read More
Manufacturers can expect more guidance on how to conduct patient preference research during device development, thanks to a $500,000 FDA grant to the Medical Device Innovation Consortium. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two CDRH device branches, under an experimental program announced Thursday. Read More