Category: Medical Writing

Pfizer Goes It Alone on Social Media

Posted on by Valentina Rosa

I wrote a blog post on December 22 entitled “FDA Misses Own Deadline On Social Media.” Some Big Pharma companies like Pfizer are defining their own rules rather than waiting for the agency to deliver their guidance in the first quarter of this year. According to an article on BNET by Jim Edwards, Pfizer has just developed its own social media playbook along with a blog response flowchart based on a version used by Pfizer Canada that was originally developed by the U.S. Air Force in December, 2008.

Edwards said that Kate Bird, Pfizer’s digital communications strategy director, said “Twitter is really the most-used channel for any type of crisis communication.” She indicated that the playbook was introduced because “We don’t want them to be intimidated and afraid of it. It’s part of our everyday life. It’s only going to become an even greater part of our everyday life.” (1)

While Pfizer’s playbook and flowchart aren’t rocket science, it does show that Big Pharma is moving forward with social media without the FDA. And Pfizer’s not alone or the first to do so. Roche created its own social media playbook in August 2010.

Notes

(1) Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Resources

Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Pfizer Canada shares its social media response flow chart

The Air Force’s Rules of Engagement for Blogging

New FDA Guidance on INDs: What You Need To Know

Posted on by Valentina Rosa

The FDA typically issues a new guidance when the agency is seeing errors in submissions and a lack of understanding in industry and academia. Most recently, the agency observed these trends regarding when and why the academic research community and industry must prepare an Investigational New Drug (IND) application before studies of a drug or biologic can begin in human subjects. In response, FDA released a new guidance document in October 2010 entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted without an IND.” The document totals just 19 pages.

Clients in our regulatory consulting & writing practice have told us that the new guidance provides an understanding of:

  • Three characteristics of research studies that create an IND requirement
  • Six criteria that must be met for a clinical investigation to be IND-exempt
  • When and if studies on healthy volunteers or studies using only a few subjects require an IND
  • When studies conducted outside the U.S. require an IND

Our clients also found the “Frequently Asked Questions” at the end of the guidance extremely valuable.

After reading the new guidance you should be able to create a checklist and determine whether your study requires an IND. Spend the time, read the guidance, and make a plan.

FierceBiotech: The Biotech Industry’s Daily Monitor

Posted on by Valentina Rosa

The tagline of FierceBiotech is “The Biotech Industry’s Daily Monitor” and they deserve it! It is a gold mine of information for anyone who works in the biotech, pharmaceutical, and medical device industries. And, for medical writers, medical communicators, and regulatory writers, the resources are amazing. There are 8 microsites within FierceBiotech, each with a specific focus in the biopharma universe. With news, features, events, eBooks, white papers, and webinars, they’re got pretty much all your content needs covered. (As an aside, FierceMarkets Network has more than 30 websites.)

What’s the best way to absorb all this information and use it on your job? I think the best approach is to go to FierceBiotech and take a look around. Once you’ve spent some time there, pick the kinds of media that are most useful to you and how you want to get it. Would you rather use an RSS feed to get links to articles of potential interest in your newsreader? Do you prefer to receive an e-newsletter or daily post? How about just bookmarking the website and using it as a resource like Wikipedia? All of these methods are possible and many more. You decide.

Do you know of other valuable resources for biotech and pharma professionals that you’d like to share?