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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager |  Regulatory Affairs |  Drug Development Consulting

In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions.

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The Push for Patient-Focused Drug Development

January 10, 2022 | Julia DiFiore, PhD  |  Clinical Research Scientist I  |  Regulatory Affairs

Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise to design studies, analyze the results, and hopefully one day submit everything to regulatory agencies so that patients can access the treatments they need.

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Keep ’em Coming: An Overview of IND Updates

June 2, 2020 | Kathryn Tworkoski, PhD, RAC  |  Principal Clinical Research Scientist  |  Regulatory Affairs, Medical Writing, Drug Development Consulting

In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of INDs.  In these earlier posts, we mentioned that INDs are “living” documents, which means that they are continuously being updated as a drug development program proceeds.  So today, we thought we’d take a few minutes to discuss the types of IND updates that you may come across.  Let’s start with…

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From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing

October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services

So you’ve decided to begin a career in medical writing – congratulations! Now what?

It may be scary leaving the comfort of your lab and pipettes, and medical writing may seem very different from academia, but you are more equipped for this transition than you may realize! (No, I’m not referring to your pipettes…)

Today, graduate students have access to several resources to help them break into the field of medical writing. While I encourage you to check these out, I also want to point out that you’re already learning valuable lessons at the bench that are applicable to any new job or work environment, including medical writing.

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Eight Things About Regulatory Medical Writing That May Surprise an Academic

August 30, 2019 | Nicole Tackmann, PhD, Clinical Research Scientist II | Medical Writing Services

The process of moving from the world of academia into the world of regulatory medical writing was an exciting and scary time for me. Luckily, I found a great place to make the transition, and I started my medical writing career at IMPACT in late 2017. At the time I thought that I had a pretty good idea of what regulatory medical writing was, but of course, I’ve learned a lot along the way!

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