MMS Blog

  • Prescription to Over the Counter Switch

    Posted on 7/1/2014 4:22 PM

    There are many regulatory considerations an organization should evaluate when transitioning a prescription drug to an Over the Counter (OTC) drug in the United States. Is the product safe in the OTC environment? Do the drug’s benefits and risks remain favorable? Does the potential for misuse and abuse remain low as an OTC drug? Can consumers adequately self-diagnose? Can consumers appropriately select and use the product in accordance with product labeling? Do users need the assistance o

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  • Avoid Common Mistakes in Disclosure Compliance

    Posted on 3/24/2014 4:25 PM

    Joe Archer, our Associate Director of Trial Disclosure Services shares his expertise with readers of Pharmaceutical Compliance Monitor regarding FDAAA rules, regulations, and common compliance mistakes. Do you know the four enforcement initiatives the FDA will be following to ensure compliance of ClinicalTrials.gov? Learn how to avoid thousands of dollars in civil monetary penalties by reading Joe's insights. With more than 24 years of experience developing and maintaining clinical process

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  • Expanding the Discussion: Assessing CV Safety in Clinical Research

    Posted on 2/25/2014 4:30 PM

    Clinical drug trials are always challenged with creating clear, standardized definitions of cardiovascular (CV) event outcomes that can be easily agreed-upon and evaluated by regulatory agencies. As data from several different clinical trials are frequently compiled to gain a fuller understanding of the investigational drug, it is important to use definitions that can be recognized across various studies. CV endpoints currently being examined in clinical studies are usually based off of a custom

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  • 7 T’s to Success of Narratives

    Posted on 2/5/2014 4:35 PM

    Medical Reviewer II If you take the time to ask a Pharmacovigilance (PV) team member, “Which project would you consider to be the most difficult?” nine out of ten times, the answer would be “Narratives”. Hearing this may surprise even the most experienced PV enthusiast and catch them off guard. With this in mind, there are multiple elements that are involved with the writing of narratives and further complexities to the process. What might be the mantra for a successful narrative project? Th

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  • Modern Approaches to Assessing CV Safety in Clinical Drug Research

    Posted on 1/28/2014 4:32 PM

    Cardiovascular (CV) events have always been a prime focus in clinical drug research, but have been of increased concern to the FDA in recent years. In 2007, a well-publicized meta-analysis by Nissen and Wolski identified an increased risk of myocardial infarction and death due to CV causes associated with the anti-diabetic drug rosiglitazone1. The FDA Endocrinologic and Metabolic Drugs Advisory Committee met in July 2008 and determined that concerns about CV risks during premarketing and postmar

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  • An Insight into the Processing of CDISC Compliant Studies

    Posted on 11/1/2013 10:03 AM

    The most developed and widely implemented concept of the CDISC standards is the Study Data Tabulation Model (SDTM). In 2010, the FDA’s Center for Drug Evaluation and Research published a data standards plan recommending CDISC standardization for the submission of clinical trial data. Utilizing the SDTM allows for greater efficiency of the regulatory review process. The SDTM benefits sponsors by enabling standardized processes and programming. The following process shows how the raw data is conv

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  • An Interview with a Principal Medical Writer

    Posted on 10/25/2013 10:37 AM

    A medical writer plays a key role at various stages of drug development. They are vital in their role as they often lead the summarization and discussion of the data a company gathers over the course of developing a drug and even beyond. Although a medical writer is well known throughout the pharma industry, few outside of the industry know who a medical writer is or what exactly they do. Without a written record of clinical studies, new pharmaceutical drugs would never gain approval by the

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  • Combination Therapy: The Path Revealed

    Posted on 9/26/2013 10:51 AM

    The recent advance in the understanding of the pathophysiological process behind some of the most common life-threatening diseases, such as cancer and AIDS, has warranted the need to develop new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets. Combination therapy is a method to treat a disease or a disorder through the simultaneous usage of different drugs having synergistic or additive potential to improve therapeutic efficacy. The final guideline

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