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Laboratory Developed Tests: Issues and Anticipated Regulations
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Blog & Updates
November 25, 2015
When serious a medical condition goes without suitable treatment, the FDA offers four programs to fast-track potential drugs through the development and review stages: • Fast-track • Breakthrough therapy • Accelerated approval, and • Priority review As we’ve learned from working with clients over the years, deciding which program is best suited for a potential […]Continue Reading
Last July, the FDA released a draft guidance on the oversight of lab-developed tests. Since then, the American Clinical Laboratory Association (ACLA) and other medical associations have spent the past year battling the proposed regulations both though tough words and the threat of legal action. The new regulations, which would subject large centralized laboratories to […]Continue Reading
“Leading with 2020 vision” was the theme of this year’s Vistage Executive Summit––an event aimed at helping business leaders stay relevant today’s fast-paced, technology-driven culture by giving executives a platform to share insights and firsthand experience. Among the speakers and breakout sessions at this year’s event in Boston, The FDA Group’s CEO and President Nick […]Continue Reading
October 23, 2015
On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for Laboratory Developed Tests (LDTs) based on risk on patients. This is a change from the current framework where regulatory oversight is determined based on whether the LDT is made by a conventional manufacturer or a single […]Continue Reading
October 16, 2015
On Monday, August 3, 2015, the Food and Drug Administration announced its fees for the Generic Drug User Fee Amendment Program. These fees apply to abbreviated new drug applications, prior approval supplements to approved abbreviated new drug applications, facilities that manufacture the active pharmaceutical ingredients for generic drugs, and facilities that manufacture finished dosage forms. […]Continue Reading
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