Citeline Podcasts

FDA's Zivana Tezak says she is pleasantly surprised at the high level of complexity that stakeholders brought to a recent meeting on using curated databases to support next generation sequencing (NGS). She says the conversations are a jumping point for the agency as it plans to hold back-to-back workshops on genomic testing in November.

FDA's Zivana Tezak says she is pleasantly surprised at the high level of complexity that stakeholders brought to a recent meeting on using curated databases to support next generation sequencing (NGS). She says the conversations are a jumping point for the agency as it plans to hold back-to-back workshops on genomic testing in November.

This week, we spoke about our latest Compliance Corner and podcast offerings to assist companies in complying with FDA quality regulations, challenges with the global Medical Device Single Audit Program, questions over diagnostics legislation and the CDRH independent assessment process.

This week, we spoke about our latest Compliance Corner and podcast offerings to assist companies in complying with FDA quality regulations, challenges with the global Medical Device Single Audit Program, questions over diagnostics legislation and the CDRH independent assessment process.

Manufacturers can find it overwhelming to address problems discovered by agency investigators following a facility inspection. Here to help is former longtime FDA official Cap Uldriks, who unveils a 12-step plan to recovering from Form-483 citations in this "Gray Sheet" educational podcast.

This week Gray Sheet journalists discussed several recent acquisitions including Valeant's buy of Synergetics, Medtronic's purchase of Medina and HeartWare's acquisition of Valtech. The also discussed a continued push to add Unique Device Identification codes to reimbursement claims and an expanded openFDA database.

Manufacturers can find it overwhelming to address problems discovered by agency investigators following a facility inspection. Here to help is former longtime FDA official Cap Uldriks, who unveils a 12-step plan to recovering from Form-483 citations in this "Gray Sheet" educational podcast.

This week Gray Sheet journalists discussed several recent acquisitions including Valeant's buy of Synergetics, Medtronic's purchase of Medina and HeartWare's acquisition of Valtech. The also discussed a continued push to add Unique Device Identification codes to reimbursement claims and an expanded openFDA database.

This week Gray Sheet journalists discussed several recent acquisitions including Valeant's buy of Synergetics, Medtronic's purchase of Medina and HeartWare's acquisition of Valtech. The also discussed a continued push to add Unique Device Identification codes to reimbursement claims and an expanded openFDA database.

This week Gray Sheet journalists discussed a new report from the FDA-sanctioned Medical Device Registry Task Force, feedback to FDA on patient-preference data, MRI compatible device launches in Europe, the Abbott-St. Jude acquisition rumor and more.