• 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

    FDA Tweaks List of Recognized Consensus Standards for Devices

    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).   The 14-page notice “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices,” CDRH said. It includes a list of the modif...
  • 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 Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial.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,...
  • Regulatory NewsRegulatory News

    Use of Standards at CBER: New Draft Guidance

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions. Questions and answers contained within the draf...
  • Feature ArticlesFeature Articles

    A New Regulatory Paradigm for Medical Devices in India

    This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes. Introduction Medical devices are a multi-billion-dollar global industry with continuous growth opportunities due to advancements in technology and new innovations. However, innovations and new advancements do not always reach patients due to a lack of clarity related to the approval p...
  • Regulatory NewsRegulatory News

    ISO: Identification of Medicinal Products Standards Revised

    The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information. "When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records," Christian Hay...
  • Regulatory NewsRegulatory News

    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
  • Regulatory NewsRegulatory News

    CDRH Clarifies Process for Consensus Standard Recognition Requests

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act . Medical device makers often rely on consensus standards in the development and testing of their products, and FDA allows device makers to submit a declaration of conformity to show that the...
  • 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

    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...
  • 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...
  • Regulatory NewsRegulatory News

    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...