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10 Tweets from FDA's Public Hearing on Off-Label Promotion

10 Tweets from FDA's Public Hearing on Off-Label Promotion

Anne Lorenzano
Written by Anne Lorenzano November 15, 2016

Last week, the FDA held a 2-day public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The meeting addressed the longstanding disagreement between the FDA and medical product manufacturers regarding the communication of off-label information. The dispute stems from the fact that physicians are allowed to prescribe a medicine or…

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Life Sciences
Top Takeaways from the 2016 American Medical Device Summit

Top Takeaways from the 2016 American Medical Device Summit

Anne Lorenzano
Written by Anne Lorenzano October 12, 2016

Last week, over 200 regulators, engineers and company executives from across the US attended the 3rd Annual American Medical Device Summit. The event’s program explored the challenges and opportunities in product development, quality management, speed to commercialization and regulatory harmonization. Attendees witnessed first-hand case studies and walked away with strategic insights to streamline processes, reduce…

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Life Sciences
4 Sessions to Follow at The American Medical Device Summit

4 Sessions to Follow at The American Medical Device Summit

Anne Lorenzano
Written by Anne Lorenzano October 4, 2016

  This coming Wednesday and Thursday, Generis will be hosting the 3rd Annual American Medical Device Summit in Chicago, Illinois. The event’s program explores the challenges and opportunities in product development, quality management, speed to commercialization and regulatory harmonization. Attendees can expect first-hand case studies and walk away with strategic insights to streamline processes, reduce…

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Life Sciences
The Who, What, How and Why of Sales Enablement for Life Sciences Companies: Part 3

The Who, What, How and Why of Sales Enablement for Life Sciences Companies: Part 3

Anne Lorenzano
Written by Anne Lorenzano September 27, 2016

In the last several weeks, we’ve discussed the what, who and how of sales enablement. Here’s a brief recap: What is sales enablement? “…strategic ongoing process that equips all client-facing employees with the ability to consistently and systematically have a valuable conversation with the right set of customer stakeholders at each stage of the customer’s…

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Life Sciences
The Who, What, How and Why of Sales Enablement for Life Sciences Companies

The Who, What, How and Why of Sales Enablement for Life Sciences Companies

Anne Lorenzano
Written by Anne Lorenzano September 14, 2016

The Series In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above. This series will unpack the elements of sales enablement, and…

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Life Sciences
The FDA's Recent Notice: Medical Product Marketers Take Note

The FDA's Recent Notice: Medical Product Marketers Take Note

Anne Lorenzano
Written by Anne Lorenzano September 8, 2016

  Last week, the FDA announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” This meeting will address the longstanding disagreement between the FDA and medical product manufacturers regarding the communication of off-label information. The dispute stems from the…

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Life Sciences
3 Things Every Pharma Marketer Can Learn from the EpiPen Price Rise

3 Things Every Pharma Marketer Can Learn from the EpiPen Price Rise

Anne Lorenzano
Written by Anne Lorenzano August 31, 2016

The EpiPen, produced by pharmaceutical company Mylan, is an emergency treatment for life-threatening allergic reactions. For the 3.6 million prescribed, the injection device is a need-to-have, not a nice-to-have. And according to ABC News, “there appears to be one other company making an epinephrine auto injector available in the U.S.” Add to that a price…

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Life Sciences