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Author Archives: Ashley Godfrey

Will the FDA Change the Way it Regulates Off-Label Promotion? One Court Case that May Have Helped Pave the Way

April 13, 2017 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

When it comes to off‑label promotion – promoting a prescription drug for a use that is not included in its approved labeling – the FDA has historically taken the position that doing so risks criminal misbranding of the product under the Food, Drug and Cosmetic Act (FD&CA). However, a number of recent court cases challenging this position on the basis that it violates the First Amendment rights of drug companies have paved the way for a potential change in the way FDA will be regulating off-label promotion. We are eagerly awaiting the release of a new FDA guidance on off-label communication. This guidance will be the subject of another blog post when it becomes available. But in the meantime, I thought I would briefly discuss the relevant history of one of the court cases, Amarin Pharmaceuticals, Inc. (Amarin) versus FDA, that helped put the potential policy changes in motion.

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How to Use Social Media to Transition into Medical Writing

January 25, 2017 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Medical Writing Services

In the previous blog post, we shared advice on face-to-face networking for people (like you!) who are looking to transition into a medical writing career. In this post, I break down some of the available social media resources and pass along some advice I learned along the way to my current role at IMPACT.

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5 Professional Networking Tips for Emerging Medical Writers

January 16, 2017 | Jacquie Powell, PhD, and Ashley Godfrey, PhD, RAC, Clinical Research Scientists | Medical Writing Services

We have talked to a number of transitioning scientists who have a hard time understanding why they should engage in professional networking. One postdoctoral fellow summed it up by saying, “I know I should network but it just feels so dirty.” This made us laugh and helped us remember our own disconnect as we were going through the process of leaving academic science to enter the field of medical writing.

In an effort to help others bridge the gap, this blog post provides 5 professional networking tips we have learned along the way.

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