Tag: regulatory writing

FDA Basics for Industry

Posted on by Valentina Rosa

The FDA has launched a new web site called FDA Basics for Industry to help companies save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry. According to FDA Commissioner Peggy Hamburg, “the goal [of FDA Basics for Industry] is to improve communication between FDA and industry by making basic information about the regulatory process more accessible and user friendly to industry.”

This short video should be of value to any professional in the regulatory writing, regulatory consulting, or medial writing fields.

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

FDA Misses Own Deadline On Social Media

Posted on by Valentina Rosa

alarm clockThe FDA promised to deliver a guidance on social media marketing by the end of this year. Unfortunately, the agency announced that it will fail to meet its own deadline. But as Pharmalot reports, the guidance has been officially postponed until the first quarter of 2011.

The pharma industry has been demanding and waiting for these guidelines for years. The agency took some steps such as holding a public hearing on the topic of social media in which participants presented their opinions about regulatory supervision of pharma’s online activities.

What does this delay means for industry? For now, there seem to be at least two options for pharmaceutical marketers: (1) keep doing what they’re doing in social media marketing, and ask for permission later; (2) what for the guidance and then start doing. There’s no panacea here. Each company has to decide for itself what is the right course of action. Either way, the waiting game isn’t much of an end-of-year present.

Related Articles

FiercePharma: As Pharma Awaits FDA Rules, Marketing Happens

Eye on FDA: Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011

Dose of Digitial: FDA Uses Social Media, But You Can’t

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.