Multimedia Consumer Products Quality + Compliance Risk Management: Taking Stock with David Patterson Welcome to Taking Stock, a podcast designed to discuss some of the most pressing issues facing corporate executives. This podcast series is ...
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 Sales + Marketing Consumer Products 1 Month Until CCPA Goes Into Effect, Is Your Business Prepared? California’s Consumer Privacy Act (CCPA) will go into effect in 1 month. Why is it important and why should direct-to-consumer, ...
Blog Post Consumer Products Grocery 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 + Compliance Consulting Services 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 and 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 Biotech Quality + Compliance What is the Future of Liquid Biopsy Diagnosis? The promising outlook for liquid biopsy diagnosis has sparked the interest of many in the biotech industry. The speed, ease, ...
Blog Post Research + Development Consulting Services 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 and 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 + Compliance 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 + Compliance Consulting Services 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 ...
Blog Post Consumer Products Health and Beauty How Close Are We to Updated Cosmetics Regulations? Health and wellness continues to gather momentum as a prominent focus of the mainstream consumer, and the movement shows no ...