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  • Regulatory NewsRegulatory News

    FDA Offers Two Draft Guidances on Drug-Drug Interactions

    The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs). FDA says the guidances, which will replace 2012 draft guidance entitled “Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations,” reflect the agency’s efforts to help drug developers design DDI studies that p...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Generic Drug-Device Combinations: A Framework for Understanding FDA Approval Requirements

    As innovations in drug delivery systems continue to emerge, so do the number of drugs with a device component. These so-called drug-device combinations include many types of products regulated by the US Food and Drug Administration (FDA), such as drugs prepackaged in inhalers and auto-injectors, transdermal patch delivery systems and various types of kits. This new breed of technologies raises several approval issues for would-be generic competitors, particularly when th...
  • 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...
  • FDA Looks to Clarify Presentation, Formatting of Drug-Drug Interaction Labeling Information

    An upcoming meeting sponsored by the US Food and Drug Administration (FDA) is looking to optimize how it presents information regarding drug-drug interactions (DDIs) to the public. Background DDIs refer to - as the name implies - the interaction of two or more pharmaceutical substances which, on their own, would not cause a patient harm. However, when the two products are taken simultaneously, the patient is more likely to experience an adverse side effect. "Drug-drug ...
  • European Regulators Issue 'Major Revision' to Guideline on Investigating Drug Interactions

    The European Medicines Agency (EMA) on Friday, 6 June issued an updated guideline on the investigation of drug-drug interactions, giving the guidance its first "major revision" since 1998. The guidance addresses the "potential for pharmacokinetic interactions between new medicinal products and already marketed drugs" and other products-including food-and how to best address drug-drug interactions (DDI) through in vitro and in vivo studies. DDIs are commonly associate...