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Asia Pacific Food and Drug Administration (FDA)

Ropes & Gray LLP

Regulation of Laboratory Developed Tests in APAC

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Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

Jones Day on

Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

Robins Kaplan LLP

Financial Daily Dose 8.7.2019 | Top Story: Novartis Hid Altered Drug Test Data From FDA

Robins Kaplan LLP on

A new report out Tuesday from the Food & Drug Administration reveals that drug maker Novartis “concealed manipulated data” from the agency “while applying for approval of an extremely expensive gene therapy treatment and then...more

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