Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|September 28, 2011
CRF Health is First to Gain FDA Registration, and 21CFR 820 Recognition, of their TrialMaxR ePRO System as Medical Device
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In accordance with the new FDA regulation, set in April this year,
TrialMax® is categorized as a Class 1 MDDS under regulation 21CFR 880.6310 (code OUG). And because it uses alarms to remind subjects when to take their study medication, it’s also classified as a ‘medication reminder’ under regulation 21CFR 890.5050 (code NXQ). This makes TrialMax® exempt from pre-market review but still subject to medical device 21CFR 820 quality standards, a practice to which CRF Health is fully compliant.
Rachael King, CEO explains, “CRF Health improves data collection by removing the barriers between intimate patient experiences and the technology designed to capture them.”
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