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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    China Food Safety Regulatory Framework

    • 25 August 2016
    This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law 1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed. Introduction Over the past 30 years, China, a developing nation with a huge population ...
  • Feature ArticlesFeature Articles

    China Food Safety Regulatory Framework

    This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law 1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed. Introduction Over the past 30 years, China, a developing nation with a huge population ...
  • Regulatory NewsRegulatory News

    FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates

    The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients. In response, FDA has provided manufacturers of the devices with new language to add to their instructions for use that includes a list of warnings and considerations to mitigate the risks. The agency also says that ...
  • Regulatory NewsRegulatory News

    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
  • Regulatory NewsRegulatory News

    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...
  • Regulatory NewsRegulatory News

    Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk

    The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach. The widely used OTC products already have warnings  about this bleeding risk in their labels, though Dr. Karen Mahoney, Deputy Director and Supervisory Medical Officer in FDA’s Division of Nonprescription Drug Products, noted that a r...