• Regulatory NewsRegulatory News

    CDRH Requests Labeling Changes on Certain Pen Needles

    In a letter to manufacturers of pen needles designed to be used with injectors, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) called for labeling updates to address the adverse events associated with improper patient use.   The request comes after the agency became aware of the reported incidents of hyperglycemia, diabetic ketoacidosis and at least one patient death through medical device reports and FDA’s adverse ev...
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    FDA Offers Recommendations on Highlights Section of Labeling

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics. Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised. In 2006, FDA's final rule on the conten...
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    FDA Issues Draft Guidance on Gluten Labeling for Drugs

    The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten. FDA says the guidance is meant to reduce uncertainty about the presence of wheat gluten in oral drugs, and that unless a drug specifically contains wheat gluten or wheat flour as an ingredient, that it expects that most drugs would contain less wheat gluten than a glute...
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    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...
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    Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels

    This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule. Introduction On 27 May 2016, the US Food and Drug Administration (FDA) published in the Federal Register its final...
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    Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone

    This article discusses the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision. Introduction Regulatory advertising and promotion professionals are accustomed to working amidst ambiguity or in the gray...
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    EMA Adds New Excipients to Labeling Requirements

    The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others. Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are thought to be inactive, though some can cause reactions in certain circumstances. For instance, lactose is commonly used as a filler in drug tablets, ...
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    FDA Draft Guidance for Medical Product Communications

    This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions tha...
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    Child-Resistant Packaging Statements in Drug Labels: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance to help ensure child-resistant packaging (CRP) statements in drug labels is clear, useful, informative and, to the extent possible, consistent in content and format. The draft, now open for comments, is meant to assist applicants, manufacturers, packagers and distributors in determining what information should be included to support the CRP statements. Background Child-resistant pack...
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    FDA Makes Drug Safety Labeling Change Information Easier to Access

    The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats. “With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technol...
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    Australia Outlines Major Drug Label Changes

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find. The changes, which will be implemented over four years beginning 31 August 2016, will be made available in Australia’s Federal Register of Legislation from 17 August 2016, along with guidance on how to apply the new labeling orders. T...
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    Plain Language Labelling Requirements

    This article describes the requirements of the guidance document published by Health Canada on plain language labelling. The Regulations Amending the Food and Drug Regulations ( Labelling, Packaging and Brand Names of Drugs for Human Use ) came into force on 13 June 2015. 1 The Plain Language Labelling amendments aim to improve the safe use of drugs and help reduce preventable harms from medication errors by making drug labels and safety information easier to read and...