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FDA Issues Report Citing Case Studies It Argues Supports Need for More Oversight of LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and...
DNA4Life Is Latest DTC Genetic Test Company to Receive FDA Letter
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Direct-to-consumer startup DNA4Life (Mandeville, La.) is the latest recipient of a letter from the U.S. Food and Drug Administration (FDA) questioning the company's marketing of an unapproved...