• CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

    It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan. Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better ...
  • Brazil's Anvisa Addressing Drug Approval Priorities

    Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year reorganization aimed at better addressing the health and economic development needs of the country and its population. One of the measures it has implemented is the establishment of an expedited review and approval procedure for medicines deemed to be priority treatments for use by t...
  • Antimicrobial Resistance Monitoring Policy Updated by FDA

    An updated strategic plan detailing the goals of the Center for Veterinary Medicine's (CVM) National Antimicrobial Resistance Monitoring System (NARMS) aims to change the way the agency samples animals, improve its data recording and reporting methods, strengthen collaborative partnerships between national and international agencies and harmonize international reporting standards. CVM, the US Food and Drug Administration's (FDA) veterinary regulatory oversight body, uses...
  • FDA Releases Strategic Plan for Veterinary Medicine Program

    The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA's Center for Veterinary Medicine. The plan, intertwined with FDA's plan for the Center for Food Safety and Applied Nutrition (CFSAN), provides seven "strategic program goals" and dozens of specific initiatives meant to carry out those strategic program goals. FDA's Foods and Veterinary Medicine...
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    A Closer Look at Strategic Alliances Between Drugmakers and CROs

    Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. Strategic alliances represent the highest level of integration between pharmaceutical companies...
  • Brazil: ANVISA Publishes 2012 Regulatory Priorities

    The 2012 Regulatory Agenda of the National Agency of Sanitary Surveillance (ANVISA) was published on 12 April in the Official Gazette (DOU) and includes the expansion of the national product surveillance system (Vigipós), as well as the publication of health guidelines for the transport of human biological material.  The priorities are grouped according to the agency's scope of regulatory authority: food, health administrative control, cosmetics, analytical...
  • With Drugs Scarce, Attention Turns to Labeling Regulations

    Worsening shortages of some critical drugs are causing some groups to criticize US Food and Drug Administration (FDA) and Center for Medicare and Medicaid Services (CMS) regulations that the groups claim are causing providers to dispose of potentially useful medications. MSNBC reports that "organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they belie...
  • CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

    The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012.  The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives. CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant infor...