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Experts Assess Cyber Security Threats in Medical Technology

https://www.youtube.com/watch?v=cqCUehGEq80 As the number of patients using medical devices – worn or implanted – exponentially grows, to what extent is their privacy or safety at risk from hackers? And, how are medical technology manufacturers, security software developers and regulators like the FDA addressing this issue of data breaches? Given the growing prominence of medical technology delivery systems ...

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FDA Social Media Hearings: Day 2

As two jam-packed days of testimony near a conclusion, one powerful theme continued to resonate from drug and device companies and associated vendors: If emergent FDA regulations on participation in social media are so onerous that they serve to deter drug and device makers from being in this arena, the commercial stage will be entirely left to unregulated entities including marketers of alternative health ...

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Adverse Event Reporting Commentary Leads Day 2 of FDA Social Media Hearings: MedWatch a Focal Point

From Jim Weinrebe, live from the hearings:Look for MedWatch to become an increasingly "go to' website for consumers experiencing problems they believe are associated with their prescription therapies.We're barely 30 minutes into the morning's agenda  on what Internet regulations should exist for adverse event reporting, and two speakers have already spotlighted the need to make the MedWatch site m ...

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FDA Social Media Hearings Part Deux: TO MONITOR OR NOT TO MONITOR? AND WHAT’S UP WITH GOOGLE?

One of the most strongly, consistently stated tenets about social media is that if a company does nothing else, it should at least actively "listen." But for regulated drug and device companies, what if listening and monitoring yields mountains of hard to vet, potentially adverse event information that must be reported? Or uncontrolled consumer discussion and posting of off-label use of regulated ...

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Commentary on FDA Hearings on Social Media

From Jim Weinrebe, EVP at Schwartz Communications, live from the FDA open hearings on use of the Internet and Social Media Tools in Promotion of FDA-Regulated Products:Four hours of testimony has just concluded, with statements from product manufacturers and their trade associations, communication firms, lawyers and non-profits and health advocates. As suggestion after suggestion piled up as to what industr ...

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BIO 2009: Despite Bleak Economy, Optimism Still Flows

Attendance is down at this year’s international BIO conference and many of the clinical stage attendees are in a frantic race against their respective burn rates, but this event once again distinguishes itself as a forum where many of the industry’s best and brightest convene to be passionate about their science and its life changing potential, despite the formidable odds faced by so many. And w ...

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Biotech Entrepreneurs Must Be Heard in Biosimilars/FDA Regulatory Pathway Debate

Have we at last reached the point where U.S. lawmakers finally establish an FDA regulatory pathway for follow-on biologics?  The Zeitgeist says it is so.  You can feel it, see it, hear it and know it. There is just way too much hurting in this economy and far too much of a mandate for healthcare reform for political gridlock or inertia to win out.And now, as they say, the Devil is in the Details, ...

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