• RF Quarterly

    Biologics compliance

    This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these regulations should be built based on a quality management system and risk management to capture changes during the product development and process validation phases and prepare a product and facility for inspection readiness. Post commercial...
  • Regulatory NewsRegulatory News

    FDA draft guidance outlines criteria for conducting benefit/risk assessments

    The US Food and Drug Administration (FDA) issued a draft guidance on Wednesday that aims to shed light on how it assesses the benefits and risks of new drugs in deciding whether to approve them. The guidance also describes how companies can present benefit and risk information in their applications to increase chances of approval.   The guidance also addresses how sponsors can collect patient experience data to inform their benefit/risk assessments. It was developed ...
  • Feature ArticlesFeature Articles

    Strategies for managing regulatory risk with third-party distributors

    In today’s global healthcare distribution market, an increasing number of medical device and in vitro diagnostic medical device (IVD) companies are aspiring to market globally. One of the main challenges these manufacturers face is how to register and distribute their products internationally. While direct distribution channels may be feasible for larger multinational corporations, third-party distribution brings its own advantages, and is becoming the norm in today’s land...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    A guide to good vendor management

    This article addresses best practices for regulatory affairs departments in their work with vendors. The author provides an overview of the vendor-contract giver relationship, then discusses finding an appropriate vendor, due diligence in selecting a vendor, vendor-related risk management, contract management, performance evaluation, maintaining the vendor-contract giver relationship, and the importance of follow-up meetings, audits, and reviews.   Introduction   A...
  • Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • Regulatory NewsRegulatory News

    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
  • Regulatory NewsRegulatory News

    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
  • Regulatory NewsRegulatory News

    Industry Calls for Changes in Two REMS Guidances

    Industry groups representing the pharmaceutical, biotechnology and generic drug industries are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on risk evaluation and mitigation strategies (REMS).   The draft guidances , released for comment in January, detail a framework for companies to develop an assessment plan for their REMS programs and provide recommendations for surveying patient and health care provider knowledge of REMS...
  • Regulatory NewsRegulatory News

    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
  • RAPS' LatestRAPS' Latest

    Risk Management: What Regulatory Professionals Need to Know

    For companies looking to develop new therapies or improve existing ones, and for the regulators overseeing them, striking right balance between potential benefits to patients and an appropriate level of risk is critical. The drive to innovate, develop new and better products, and help patients live healthier lives has led to numerous medical breakthroughs. But it is just as imperative that products are as safe as possible, and that where there are associated risks, they a...
  • RAPS' LatestRAPS' Latest

    GSK's Sue James Praises RAPS' Regulatory Competency Framework

    In 2016, RAPS released its Regulatory Competency Framework , a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations began using the Framework immediately. We spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and how it has been used at GSK. Regulatory Focus : What do you see as th...