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    The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs). FDA says the guidances, which will replace 2012 draft guidance entitled “Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations,” reflect the agency’s efforts to help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

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    EMA Sees Increase in Early Dialogue with Biosimilar, New Drug Developers

    The European Medicines Agency (EMA) is seeing a sharp rise in demand from drug developers seeking dialogue earlier in the drug development process, particularly for biosimilars and drugs with a new active substance, EMA's management board said Tuesday in an update on the first half of 2015. Of the marketing authorization applications for drug products containing a new active substance and for biosimilars that were submitted in the first half of 2015, 77% had received sci...
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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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    With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

    The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and Drug Administration (FDA) in the hopes of improving the drug development process, it announced today. The survey is specifically meant to inform negotiations over the next iteration of the Prescription Drug User Fee Act (PDUFA), which was last authorized in 2012 and it...
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    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...
  • CDRH, CBER Finalize Medical Device Review Communication Guidance

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions. Those submissions include premarket applications (PMAs), PMA supplements, biologic license applications (BLAs), BLA supplements and premarket notifications [510(k)s]. Background The guidance is intended to reflect changes undertaken by the agency under two pieces of legi...
  • 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...
  • Study: Benefits of Some Cancer Drugs Mitigated by Other Drugs

    Many cancer patients taking oncology drugs might see the beneficial effects of their medication fail to materialize if they are taking other medications, says a new study by Medco Health Solutions Inc. The Medco study found between 23% and 57% of patients taking cancer drugs for a specific cancer were also taking medications that could alter the effects of the drug, including decreased effectiveness and increased toxicity. "For Gleevec, 43% of the 4,617 cancer patients ...