Wait, Wait…Don’t Sell Me! FDA and Other Pre-Market Considerations for Commercial Products

The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food, including animal food, and electronic products that emit radiation. Canada’s equivalent is Health Canada (HC) and focuses on helping Canadians maintain …

Risk-Based Contracting: How does taking on risk contribute to value-based care?

As healthcare laws are ever-evolving, the latest shift in the industry centers around value-based care. In fact, value-based care has recently become exceedingly popular, because it seeks to streamline healthcare while also cutting costs. It is both patient- and practice-centric. To achieve lawful value-based care, at least two value-based enterprises must enter into a value-based …