The Writing Docs

Why do most FDA submissions fail? What’s the balance of information you should put in a document? What are the real reasons behind "cease to evaluate" designations and how can unvetted AI tools create substantial regulatory risk?
Discover the answers to these questions and more with Carrie McMahon who has more than 22 years of experience in the FDA. Carrie gives us insight into how FDA regulators view documents with both scientific and legal lenses. Plus, she explains how to avoid mistakes that stop many submissions and GRAS documents from getting FDA approval.
 
Carrie McMahon
Connect with Carrie: https://www.linkedin.com/in/carriehmcmahon/
Dr. Carrie McMahon (PhD in cell/cellular and molecular biology) worked in the FDA for over 22 years in food ingredient safety assessment and regulation. She worked within programs responsible for reviewing applications on new food ingredients and on food from genetically-engineered and genome-edited food crops. Her FDA experience includes (but was not limited to) project manager for the review of GRAS notices, team lead of the Human Foods Biotechnology Team, program manager for Plant Biotechnology Consultation programs, and subject matter expert for supporting the education and communication for the public, media, regulated industries, and foreign regulators. Carrie now shares her wealth of knowledge about the FDA at her company Feed My Mind Regulatory Consulting LLC.

How Do FDA Regulators Actually Read Your SOPs and Reports? When an FDA investigator picks up your investigation reports, SOPs, or FDA submissions, they aren’t grading your commas. Rather, they’re looking at the person or animal at the end of the line. In this episode of Writing Docs, former FDA Director of the Bioresearch Monitoring Division (West) Eric Pittman joins us to demystify regulatory reviews. Eric reveals what regulators actually evaluate during an inspection, why "cover-your-butt" language hurts readability, and how poor critical thinking (not bad grammar) leads to warning letters. Tune in to learn why clarity, root-cause logic, and understanding your readers are the true keys to voluntary compliance and success with the FDA. Eric Pittman Connect with Eric: https://www.linkedin.com/in/ericspittmanmba-fda/ Eric Pittman worked in the FDA for over 20 years and was the director of the FDA’s Bioresearch Monitoring Division (West) as well as the FDA delegate to the Organization for Economic Cooperation and Development’s (OECD) Working Party on GLPs. He's also had leadership roles at AbbVie and now leverages his expertise in regulatory affairs and quality assurance as the vice president at Project Farma.

How do you avoid editing mistakes? What are some of the worst editing mistakes? What does all of this mean for writing clearer and more concise documents? Join The Writing Docs and Hurley Write Executive Consultant, Jared Daigle to discover editing secrets.

Season Two of Lion in the Mirror kicks off with a fighter. Pam Hurley—President & CEO of Hurley Write, technical-writing renegade, and self-proclaimed rebel—sat down with us to talk through the wreckage, the redemption, and the raw truth of becoming herself. Pam didn’t take the clean path. She missed out on UNC Chapel Hill, thrived at UNCG, then—like so many born in this state—jumped at the chance to wear Carolina blue when it finally came calling. The decision, as she tells it, was glorious, ill-advised, and powered by pure Tar Heel mythology. One Winnebago joyride, one judgmental landlord, and one catastrophic brush with college math later… she flunked out. Hard. Drifting. Directionless. Bruised. And then she stood up. UNCW became the ground she rebuilt from. There, Pam found her innate necessary: the power of giving people the validation they’ve been starved of. She leaned into it, grew into it, and eventually carried it all the way into her Ph.D.—where she rejected the old sacred cow of Composition Studies and reframed technical writing as problem-solving rather than literary analysis. Today, she’s the CEO she never met growing up. A survivor who refuses to let victimhood name her. A rebel who insists on seeing people clearly—and teaching them to see themselves. From Pam, you’ll walk away with a handful of hard-earned truths: Seeing someone is not small. It can reroute a life. If something isn’t your fit, stop trying to shrink yourself into it. Change the thing. Proving your worth to people who don't think you're worthy is a fool’s economy. Your rebellion is a tool—aim it. Conventional wisdom is often just someone else’s fear dressed up as advice. Talk to yourself with the same decency you give the people you love. Your upbringing, even the violent parts of it, does not get to write your destiny. And maybe the line that sums Pam up best: “Do not be afraid.”

In this episode, Pam Hurley, PhD, President of Hurley Write, Inc., discusses the value of clear communication in leadership with Heather Walker, PhD, the podcast host of Lead with Levity. 

They need time and space, but most organizations don't provide this. 

Your team needs time and space to produce effective documentation; listen to this podcast episode to learn more. 

If you've ever wondered why your team isn't producing quality documents quickly, it's because effective writing requires time and space. Learn what that means in this engaging podcast. 

It's a common complaint: why can't my employees write well? The answer: blame it on academia. That's right--the writing courses they took in college didn't prepare them to write for the workplace and the feedback their professors gave them on writing did little to improve their writing.
The good news? Improving your team's writing is possible with the right tools! 

Many organizations call us complaining about their team's writing and blame it on poor grammar. But knowing where to put a comma or how to make the subject and verb agree isn't the issue: the issue is that your team doesn't think about writing strategically.