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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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    Grouping Supplements for CMC Changes: FDA Outlines New Policy

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant. The agency says the goal of its new policy is ...
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    Postapproval CMC Changes: FDA Updates Guidance

    Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised draft provides recommendations to drug manufacturers on implementing CMC postapproval change(s) through the use of a CP. Companies that fall within the scope of this guidance will not have to...
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    New Studies Push FDA to Expand Label for Popular Diabetes Drugs

    Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was stro...
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    FDA Requires New Labels for Opioids

    The US Food and Drug Administration (FDA) on Tuesday announced class-wide safety labeling changes for immediate-release (IR) opioid pain medications, which make up about 90% of all opioid prescriptions. The labels now include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on their risks, w...
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    PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes

    The US Food and Drug Administration (FDA) should work more closely with the International Conference on Harmonization (ICH) on the reporting of chemistry, manufacturing and controls (CMC) changes for approved drugs and biologics, according to the industry groups’ comments on proposed FDA draft guidance. The FDA draft guidance , known as Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products and released in June, lays out new recommendat...
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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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    Making Changes to an Already-Approved Drug? FDA's New Guidance Wants to Help

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding how manufacturers of pharmaceutical products can make changes to their manufacturing equipment under FDA's scale-up and post-approval changes (SUPAC) requirements. Background After a pharmaceutical product is approved, its sponsor and manufacturer must work to meet ever-changing manufacturing standards, as well as demand for the drug. Though the drug product itself is still ap...
  • Draft Guidance Describes Change Notification Process for Blood Products

    A new draft guidance document released by the US Food and Drug Administration (FDA) regarding making approved human blood and blood components lays out the agency's recommendations on which changes to a product or its manufacturing processes will require notifications to be made to the agency, and how to do so in a least-burdensome manner. Three Main Types of Changes The guidance, released 31 May 2013, is specifically intended for manufacturers of licensed whole blood a...
  • EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

    The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of regulatory implications for pharmaceutical companies. Holders of marketing authorizations (MAHs) are legally required to have their product information, including labeling, available in the official languages of all EU member states. As of March 2013, there are 27 such states, stretc...
  • Brazilian Regulatory Authorities to Expedite Minor Labeling Changes

    Brazil's national regulatory authority, Anvisa, has announced that its Board has approved an amendment that will permit its regulators to immediately approve minor labeling changes upon notice by a pharmaceutical company. The new rule, approved 12 December 2012, covers changes that pose no risk to the consumer such as safety information and packaging color, size, and layout of patient leaflets and package labeling. According to the CEO of Anvisa, Dirceu Barbano, the ne...