The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Testicular Toxicity Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a drug might have adverse effects on the testes and when clinical trials are necessary to assess those risks.   Specifically, the 14-page guidance lays out recommendations for identifying nonclinical signals that suggest risk of testicular toxicity; conducting nonclinical assessments to further evaluate the ris...
  • Regulatory NewsRegulatory News

    Clinical Trials: FDA Releases Two Draft Guidances

    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial. The draft also advises sponsors on the types of information FDA needs to evaluate the results from trials with adaptive designs,...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
  • Feature ArticlesFeature Articles

    The Path Less Followed - Submission Guidance for Responsive Design Websites

    This article recommends an operational path forward for streamlining the development and review of "responsive design" websites for pharmaceutical products promotion. Introduction It is no secret. The Internet has become the first stop for adults seeking health-related information. 1 At the beginning of the Internet revolution, prospective patients were limited to getting their information on desktop terminals.  As Internet accessibility expanded into mobile devices,...
  • Regulatory NewsRegulatory News

    Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies

    Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA). This guidance describes the recommended approach to an adhesion clinical study design used to support an abbreviated new drug application (ANDA) and, once finalized, the guidance will supersede FDA’s prior recommendations related to a...
  • Feature ArticlesFeature Articles

    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
  • Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
  • Regulatory NewsRegulatory News

    FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity. Known as  adaptive design , the method can minimize clinical trial sponsors’ resou...
  • Regulatory NewsRegulatory News

    FDA Tries to Improve Safety, Reliability of Home-Use Devices With New Guidance

    The US Food and Drug Administration (FDA) has finalized a draft guidance intended to clarify how manufacturers should design and develop medical devices primarily used by a patient in their own home—so-called "home use" devices. Background FDA released the draft version of the guidance in December 2012 as part of its 2010 " Home Use Initiative ." As explained by FDA, the initiative is intended to "support the safe use of medical devices in the home." For example...