• Regulatory NewsRegulatory News

    European Commission Recommends Changes to SmPC, Package Leaflets

    The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs. In its report, the Commission says that the European Medicines Agency (EMA) should update its guidelines to improve the comprehension and readability of package leaflets (PL) and summary of product characteristics (SmPC) to safe use of drugs in the EU. The report itself takes into account the resul...
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    GPhA Questions Legality of FDA Guidance on Physical Attributes of Generic Drugs

    The Generic Pharmaceutical Association (GPhA) is raising a number of concerns, among them the legality, of the US Food and Drug Administration's (FDA) recently issued final guidance on the size, shape and other physical attributes of generic drugs. Background Since at least 2013, FDA has called on generic drug companies via draft guidance to gauge the physical differences -- including size, shape, smell, weight and surface area – and try to make generics as physically...
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    FDA to Study Effect of Generic Drug Appearance on Patient Adherence

    Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. Background FDA has long been interested in the physical attributes of drugs, and in particular generic drug products. In December 2013, for example, it released a new guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules . In it, FDA explained tha...