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Laboratory Developed Tests: Issues and Anticipated Regulations
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Blog & Updates
October 2, 2015
In 2002, FDA launched an initiative entitled, “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. In an effort to support that initiative, FDA released a draft guidance document titled “Request for Quality Metrics: Guidance for Industry” in July of 2015. This draft […]Continue Reading
September 25, 2015
On August 27, 2015, the Food and Drug Administration issued a guidance that establishes a naming convention for biologicals. Included among these biologicals are biosimilar products. The issuing of this guidance serves to resolve debates on how such compounds should be named. According to the guidance, biosimilar products will share the same nonproprietary name as […]Continue Reading
September 18, 2015
Nanotechnology is one of the newest areas in the pharmaceutical industry. Although nanotechnology has shown promise in increasing the bioavailability of pharmaceuticals, the clarity of radiographic procedures, and the effectiveness of targeted therapies, the Food and Drug Administration considers the changes in the products manufactured with nanotechnology to be in need of further assessment to […]Continue Reading
September 11, 2015
Personalized medicine has attracted much interest within the healthcare community during recent years. More physicians are striving to customize their medical treatments to their patients’ unique genetic makeup and circumstances. However, personalized medicine poses a number of regulatory challenges. As such, pharmaceutical executives should understand these challenges and how they affect the industry. What Is […]Continue Reading
September 4, 2015
In addition to approving pharmaceuticals and biologics, the Food and Drug Administration is responsible for determining whether an approved treatment is safe. As such, they require the companies that manufacture these treatments to report on adverse events that patients experience after a treatment is approved. Pharmaceutical companies should understand the appropriate mechanisms to submit these […]Continue Reading
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