Blog Post Quality & Regulatory Life Sciences Moving From a LIMS Assessment to a LIMS Deployment Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...
Blog Post Life Sciences Consumer Healthcare OTC Monograph Process FDA Reform After two years of stalled progress on approving legislation for FDA reform of Over the Counter (OTC) Monograph Drug Review, ...
Multimedia Quality & Regulatory Consumer Products Addressing an FDA Form 483 You are in the middle of an FDA inspection and a significant issue just surfaced. How you handle the situation ...
Blog Post Life Sciences Medical Devices How the Upcoming European Medical Device Regulations Deadlines Impact You Changes are all around the medical device industry, especially with the upcoming European medical device regulations deadlines quickly approaching. Revenue ...
Blog Post Biotech Pharma FDA Gene Therapy Guidances: The Latest Updates Explained On January 28, 2020, the highly anticipated final FDA gene therapy guidances were released. In total, 7 guidance documents were ...
Blog Post Consumer Products Quality & Regulatory CBD in Retail: What Do Retailers Need to Know? [Update] Since the original publication of this piece, the FDA has issued more information on its position relative to CBD. The ...
Blog Post Quality & Regulatory Life Sciences How Does the FDA Regulate Mental Health Apps? The rise of mental health apps promises an accessible option for diagnosis and treatment as more individuals want to be ...
Blog Post Consumer Products Food & Beverage Food Safety and Recalls: Emerging Regulations Governing US Based Food Companies The FDA’s 2011 Food Safety Modernization Act (FSMA) has been transforming the U.S. food safety system, with ongoing implementation creating ...
Blog Post Research & Development Life Sciences Stepping Away from Convention in Clinical Trial Design Clinical trial design, like much of the industry, is experiencing a wave of innovation and disruption. Classical randomized control trials ...
Blog Post Food & Beverage Information Technology HACCP in the 21st Century Even after the introduction of HARPC (Hazard Analysis and Risk-Based Preventive Controls) under the FSMA (Food Safety Modernization Act), the ...
Blog Post Generics Quality & Regulatory The State of Biosimilars in the U.S. The global market for biosimilars is estimated to reach $15 billion by 2020 or 2021. While in Europe biosimilars have ...
Blog Post Quality & Regulatory Life Sciences How Realistic is the U.S. Importation of Canadian Drugs? On July 31, 2019, the White House announced an iterative healthcare plan that would allow the importation of Canadian drugs ...
