The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. (RAPS Regulatory Focus)
Top 10 regulatory issues for today’s drug developers
Regulatory issues include — The FDA’s new Super Office of Pharmaceutical Quality; The new risk/benefit equation; 21st century pharmacovigilance; Biosimilars; Patient-focused drug development; and more. (YourEncore.com)
FDA accepts NDA for first-ever digital medication
Otsuka Pharmaceuticals and Proteus Digital Health released a joint statement on September 10 revealing the Food and Drug Administration (FDA) accepted their new drug application (NDA) for the first sensor-embedded version of Abilify for depression. (Drug Discovery and Davelopment)
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