USAMMDA Medical Writers Play Key Role Preparing Documents for FDA Review
You are an investigator toiling away at an investigational new drug application that you and your team are under a tight deadline to submit to the U.S. Food and Drug Administration. The clock is ticking. You sit in front of your computer wrestling with the table of contents in Microsoft Word. You change gears and begin writing and rewriting your general investigational plan, but no matter how hard you try, your paragraphs fail to flow together logically. If this fictional character sounds like you, perhaps it's time you make arrangements to access the services of your local medical writer.
The U.S. Army Medical Materiel Development Activity's Regulatory Operations branch employs four medical writers poised to assist both internal U.S. Army Medical Research and Materiel Command staff and external specialists that work on FDA-regulated studies for USAMRMC-supported projects.
USAMMDA's medical writers work with investigators, scientists, program managers and subject matter experts to write information packages that effectively and succinctly describe a project in a way that is easy for others to understand, according to Christine Gallo, a medical writer with USAMMDA for seven years.
When researchers determine that an USAMRMC initiative is a viable candidate for further development, the team collects data to establish that it will not expose humans to unreasonable risks during clinical studies. By working through their Regulatory Affairs Scientist, subject matter experts can coordinate medical writing assistance to clearly communicate pivotal information about the effort, so that the FDA, in turn, can review and approve the request.
Medical writers help break down highly scientific terminology and explain pharmacological concepts and procedures in laymen's terms. According to Tracy Ulderich, chief of USAMMDA's Regulatory Operations, USAMMDA's medical writers have more than 75 years of combined experience writing, editing, revising, and reviewing technical and scientific documents.
Gallo shared that with oversight from the designated Regulatory Affairs Scientist, she and her teammates can either work with a subject matter expert to develop a submission in its entirety, or edit and revise documents at various stages in the document preparation process. In addition to helping their clients create a concise, easy-to-understand package, the team is well-versed in FDA submission and formatting requirements.
USAMMDA's medical writing team works most often on Investigational New Drug applications which include animal pharmacology and toxicology studies, manufacturing information and clinical protocols, and investigator information. On its website, FDA states that these components help the FDA determine whether the product is reasonably safe for initial testing in humans; whether a company can adequately manufacture and supply consistent batches of the drug; and whether initial trials will expose subjects to unnecessary risks.
"Depending upon the product, these submissions can be thousands of files or as few as five," said Gallo.
Commenting on the support he received from the medical writing team in developing documentation for a new experimental protocol, USAMMDA Product Manager Lt. Col. Keith Scorza said, "I am a subject matter expert, not a writer. They walked me through the editorial process and shaped the document, while shaving time off the schedule." Scorza added that the team was a "lifeline" and extremely responsive to deadlines.
Despite the challenges the medical writing team tackles editing and formatting massive amounts of information, their biggest challenge is getting potential clients to understand that the team can help them, Gallo admitted.
"We understand that when teams are working under tight deadlines, they may not want an additional reviewer. However, documents that go through medical writing are more consistent, easy-to-read, and compliant with submission requirements, which can improve the efficiency of other reviews," said Gallo.
To learn more about the services provided by USAMMDA's medical writing team or to formally request team assistance send an email to firstname.lastname@example.org stating the project type and the deadline.