• Regulatory NewsRegulatory News

    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...
  • 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, NIH & Industry Advance Templates for Clinical Trial Protocols

    • 03 May 2017
    The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of NIH-funded Phase II and III studies both time and money. "The FDA and NIH see protocol harmonization as an essential component to the accelerated delivery of medicines to patients. Having aligned templates will help enable health authorities to receive consistent, high-qualit...
  • Regulatory NewsRegulatory News

    FDA Revises Guidance on Special Protocol Assessments

    The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials. Under the hopes that the SPA process will improve the quality of clinical trials, FDA has made significant changes from 2002 guidance, including: Clarification on which protocols are eligible for SPA; The addit...
  • Regulatory NewsRegulatory News

    Postapproval CMC Changes: FDA Updates Guidance

    Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised draft provides recommendations to drug manufacturers on implementing CMC postapproval change(s) through the use of a CP. Companies that fall within the scope of this guidance will not have to...
  • Regulatory NewsRegulatory News

    NIH, FDA Release Streamlined Clinical Trial Protocol Template

    In an effort to increase the efficiency of clinical trial protocol reviews, the National Institutes of Health (NIH) has released a draft protocol template developed in collaboration with the US Food and Drug Administration (FDA). The draft protocol, developed by the NIH-FDA Joint Leadership Council (JLC), will apply to NIH-funded Phase II and III clinical trials done in support of an investigational new drug application (IND) or investigational device exemption (IDE). T...
  • Regulatory NewsRegulatory News

    EMA in 2014: A Landmark Year for Approvals, With Eyes on the Future

    In the European Medicines Agency's (EMA) Annual Report 2014 , top regulatory officials describe the agency's role as both a "gatekeeper" and "enabler." This dual role means that the agency must not only work to ensure the safety of patients in the EU, but also to facilitate the development of new and innovative therapies. By the Numbers 2014 was a landmark year for EMA in many ways. The agency recommended record numbers of products to treat rare diseases , launched it...
  • Regulatory NewsRegulatory News

    Senators Want Detailed Data on FDA's Compassionate Use Program, Including Potential Improvements

    Three Republican legislators are pressing the US Food and Drug Administration (FDA) to provide them with information about its application of its expanded access regulations, saying they are in the midst of performing "oversight" over the program. Background FDA's expanded access regulations, sometimes referred to as its "compassionate use" program, allow patients to access clinical trials they otherwise might not be eligible for. The program is meant to offer ho...
  • FDA Finalizes Guidance on 'Dear Healthcare Provider' Letters

    The US Food and Drug Administration (FDA) has released a final guidance that aims to clarify the agency's requirements for information contained within "Dear Healthcare Provider" (DHCP) letters. Background The letters-so-named because they often begin with that exact salutation-are usually bulk mailings sent out by a manufacturer when it has been made aware of a serious problem with a drug or biologic, or when there is a need to provide updated information to the health...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

    The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...