• Regulatory NewsRegulatory News

    FDA Details Combination Product Postmarket Safety Reporting Requirements

    The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting. In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017. Weiner ...
  • Regulatory NewsRegulatory News

    Public Citizen Petitions FDA to Pull Some IV Solutions

    Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions. According to the petition, there are two main categories of IV solutions: crystalloid and colloid. Colloidal solutions, including HES, have largely the...
  • Regulatory NewsRegulatory News

    Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

    A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The proposed rule, unveiled in August , would require a complete quality system approach for these safety ...
  • Regulatory NewsRegulatory News

    Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

    A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death. The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety. Specifically, the authors looked at the number of adverse events reported to the ...
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    FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

    The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations. The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new guidance is for the following activ...
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    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
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    Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

    The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill. The bill’s path to success, following the House’s positive vote last week, took a unique route, with the House also passing a previous iteration back in July 2015, and then the Senate trying to craft its own package of bills, which stalled and looked to be dead as recently as September. The wide-ranging, nea...
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    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
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    FDA Revises Guidance on Safety Testing of Drug Metabolites

    The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH guidance, known as M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authori...
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    FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

    • 04 October 2016
    The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs). The guidance is intended to help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval. This is FDA’s third r...
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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...
  • Feature ArticlesFeature Articles

    Surviving Your First FSMA Inspection

    This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices. Introduction Without question, the US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is the most significant food safety law of our generation. The original Federal Food, Drug, and Cosmetic Act of 1938, included a single sentence ...