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    ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers

    The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.   The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedb...
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    EMA Looks to Revise Guideline on Investigation Drug Interactions

    The European Medicines Agency (EMA) has proposed to change the agency's guideline for investigating drug interactions. The guideline, last updated in 2012, details how drugmakers should conduct interaction studies to evaluate the potential for drug-drug and drug-food interactions. "Drug-drug interactions are a common problem during drug treatment and give rise to a large number of hospital admissions as a result of medically important, sometimes serious or even fatal ad...
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    EMA Drafts New Clinical Development Guideline for Fixed Dose Combination Drugs

    In response to a rise in the use of fixed dose combination (FDC) drugs, the European Medicines Agency (EMA) has revised its guideline addressing the clinical development requirements for FDCs. Background FDCs—or drugs containing multiple active ingredients—are used to treat a variety of medical issues, ranging from the common cold to tuberculosis and HIV. For many treatments, combining multiple active ingredients can result in a simpler, more effective treatment regime...
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    How Does the Pharmaceutical Industry Really Work? FDA Wants its Managers to Know

    The Center for Drug Evaluation and Research (CDER) has announced that it plans to continue a program which allows pharmaceutical companies to invite regulators to visit their manufacturing sites to better understand how the industry operates. Background The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the "Site Tours" program, has been in effect in various forms since 1999, when it was created by CDER's Training a...
  • FDA to Continue Regulatory Training Program That Brings Together Regulators and Industry

    US pharmaceutical regulators have announced that they will continue a regulatory program that allows companies to invite officials from the Center for Drug Evaluation and Research (CDER) into their facilities to learn more about how the industry works. Background: Site Tours Program The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999 when it was c...