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The FDA’s monitoring of in-house emails of five agency whistleblowers that went public with product safety complaints was not supported by agency policy and may have violated the Fourth Amendment and the Whistleblower Protection Act, House Republicans and an HHS watchdog charged Wednesday. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
There’s now a strong possibility the European Parliament won’t finalize proposed medical device and IVD regulations before elections this May, a lawyer familiar with the legislation says. Read More
Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-generated reports, the agency says. Read More
Neuropsychiatric interpretive EEG assessment aids should undergo clinical performance testing to demonstrate the accuracy, precision and reproducibility of results, including any specified cutoffs, the FDA says. Read More
FDA’s continued progress under MDUFA is allowing AdvaMed to shift some of its focus from the pace of premarket reviews and approvals to the Center for Medicare & Medicaid Services’ methods for making coverage decisions on new technologies, association officials said Tuesday. Read More
Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More