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The Power of Inclusion: Navigating the FDA’s Diversity Action Plan

In December 2022, Congress passed the Food and Drug Omnibus Reform Act (FDORA), which requires, among other things, that drug and device sponsors submit diversity action plans for clinical trials that commence enrollment 180 days after publication of the final guidance. FDORA codifies a long-standing push by the US Food and Drug Administration (FDA) to…

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FDA Convenes Experts to Address Knowledge Gaps in Noninvasive Testing for NASH

“Silent killer” is an apt description for a potentially fatal disease that progresses slowly, without any obvious symptoms in the early stages. When you couple this insidious type of pathology with a rapidly increasing prevalence, the disease is often described in terms akin to an epidemic. Nonalcoholic steatohepatitis (NASH)—a disease characterized by fat accumulation in the…

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PNAS Spearheads Effort to Streamline Authorship Transparency

Authorship is a hot topic in the scientific and medical publishing world. Who qualifies as an author? Who is the senior author? What are the responsibilities of the corresponding author? Opinions vary across disciplines and cultures. Whereas medical publications generally follow the recommendations of the International Committee of Medical Journal Editors (ICMJE; http://www.icmje.org/icmje-recommendations.pdf),1 academic publications…

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What the New ICMJE Requirement for Data Sharing Statements Really Means for Data Sharing

As of July 1, 2018, manuscripts submitted to International Committee of Medical Journal Editors (ICMJE)-member journals must be accompanied by a data sharing statement. What is the new requirement, how did it evolve, and what does it mean for data sharing? In January 2016, the ICMJE proposed that authors of all clinical trial manuscripts published…

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The Target Product Profile—Your Blueprint for Drug Development

When utilized to its full potential, the Target Product Profile (TPP) is a dynamic, living document that ensures all stakeholders—clinical, regulatory, quality and manufacturing, commercial, market access, and medical affairs—are working from the same blueprint. Unfortunately, the TPP often has a bad rap within industry because many people think it is too rigid for today’s…

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Common Protocol Template—Streamlining Protocol Implementation

Study protocols are required for every clinical trial. Approximately 20,000 are submitted and posted to www.clinicaltrials.gov every year1—each one different. The format and core content can vary from sponsor to sponsor, costing the US Food and Drug Administration (FDA) time and resources to interpret, review, and ultimately, approve each uniquely complex protocol. This process, as…

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Mapping a Successful Path to Label Optimization

Bringing a drug to market is a long and expensive process. An analysis by the Tufts Center for the Study of Drug Development estimated the total cost of development from discovery to commercialization at $2.6 billion over the course of about 10 years (based primarily on big pharma companies). This represents more than a 10‑fold…

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How To: 5 Critical Steps to a Successful Scientific Symposium

Scientific symposia at medical conferences are a great way to educate physicians on the current treatment landscape and on how new agents can improve patient care. But your symposium is often competing with many others for attendees’ limited time and attention. If you want your content to be seen, you need to find creative ways…

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GPP3: Is It a Better Guidance?

The International Society for Medical Publication Professionals (ISMPP) recently released its latest guidance—GPP3, or Good Publication Practice 3. This is the first update of the ISMPP guidance since GPP2 was released in 2009. A steering committee first met to draft the guidance, and then ProEd colleagues, Laura McCormick, PhD; Heather Hlousek, and Jim Cozzarin, ELS,…