Keys for the Commercialization of Medical Devices in the US

Keys for the Commercialization of Medical Devices in the US

Laws and regulations
By Maria Jose Lopez Barragan, Ph.D. Markentry USA Partner and Juan Rivera-Mata, Ph. D. Markentry USA Partner Many companies plan their entry into the American market without a good understanding of the legal requirements that govern their products in the US. The FDA (Food and Drug Administration) regulates the consumption not only of drugs and food, but also of veterinary products, cosmetics, tobacco, and so-called “medical devices”.About one-fifth of what American consumers spend is, in one way or another, regulated by the FDA Under the category of medical devices there is a wide variety of products that ranges from complex devices that assist robotic surgery or even artificial organs, to objects that accompany our daily lives and whose perception can be very different from what anyone would consider a medical…
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COVID-19: Is the vaccine safe? Should I get it? – Perspectives from the US

COVID-19: Is the vaccine safe? Should I get it? – Perspectives from the US

Blog
Given the evolution of the pandemic and the news about vaccines, many of us may be asking ourselves these questions right now, which we will try to answer with a double approach: technical and social, individual and collective. Is the vaccine safe? By María José López Barragán, Ph.D. Markentry USA Partner Despite the deep concern for our physical and mental health and for the economic situation, many citizens confess not wanting to be vaccinated, now that we almost touch the first version of that coveted vaccine with our fingers. The main concern: side effects. Nobody wants to be "first." These beliefs reflect a significant gap in the information that is distributed each day. Society is bombarded with efficacy data (70%, 90%, 95%, 96%) and technical details (RNA, DNA, attenuated viruses, viral…
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Biopharma perspectives 2021-24 with Trump or Biden

Biopharma perspectives 2021-24 with Trump or Biden

Business Development
By Juan Rivera-Mata, Markentry USA Partner The US elections may entail different scenarios for the biopharmaceutical industry. During his term, Trump has tried to eliminate “Obamacare” (a law that, among other things, makes it mandatory for companies to provide health insurance to their employees), and Biden has used that possibility as a main element of his campaign. But, at the same time as the President, local and state officials are also elected, and the House of Representatives and 1/3 of the Senate are renewed. It appears that Democrats will remain a majority in the House, but the Senate, now Republican, may go "blue." Trump has appointed 3 members of the Supreme Court - for life -, making it (6/3) conservative. The obligation to have health insurance (and any subsequent reform) will…
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