• Regulatory NewsRegulatory News

    ICMRA: Address artificial intelligence challenges with permanent working group

    The rapid expansion and evolution of artificial intelligence (AI) will challenge the current regulatory pharmaceutical and device, according to a new horizon-scanning report from an international consortium of regulators. The ad hoc group recommends a permanent working group to stay abreast of the regulation of AI in the development and assessment of medicinal products.   A 6 August report from the International Coalition of Medicines Regulatory Authorities (ICMRA) d...
  • Regulatory NewsRegulatory News

    FDA defends Aduhelm's accelerated approval, while others call for reform

    Three papers published as Viewpoints in JAMA Internal Medicine this week highlight the rationale provided by the US Food and Drug Administration (FDA) on the agency’s approval of aducanumab (Aduhelm; Biogen Inc), implications the approval could have for the Medicare program, and a contemplation on the future of FDA’s accelerated approval pathway.   Writing on behalf of FDA, Billy Dunn, MD, director of the Office of Neuroscience with FDA, and colleagues said the agenc...
  • Regulatory NewsRegulatory News

    Woodcock calls for investigation into Aduhelm approval

    The US Food and Drug Administration’s acting head has called on the Inspector General at the Department of Health and Human Services to conduct an investigation into matters related to the agency’s recent controversial approval of Biogen’s new Alzheimer’s disease drug Aduhelm (aducanumab).   Janet Woodcock, acting director of the US Food and Drug Administration (FDA), took to Twitter early Friday afternoon to make the announcement, sharing the letter she sent to Christ...
  • Regulatory NewsRegulatory News

    Ethical Guidelines for Human Research Revised

    The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants. According to CIOMS, the revision aims to address challenges and shortcomings with the previous revision from 2002, especially related to value and fairness of research involving human subjects. In 1982, CIOMS released its first set of guidelines aimed at creating a set of international...
  • Regulatory NewsRegulatory News

    Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments

    President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...
  • Regulatory NewsRegulatory News

    Indian Regulators Call for Comment on Revised Clinical Trial Standards

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO), the country's medicines regulator, is seeking input from the public on draft revised accreditation standards for clinical trials. The standards were prepared by the National Accreditation Board for Hospital...
  • Regulatory NewsRegulatory News

    India’s CDSCO Releases New Clinical Trial Guidelines

    India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...
  • India's Health Ministry Releases New Clinical Trials Requirements

    India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics. Background India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country ...
  • New Rules Set to Overhaul Indian Clinical Trials Framework

    Indian regulators are out with two new clinical trials regulations that promise to reform some of the ethical hurdles that had plagued the sector in the past, including lax approval standards and a lack of compensation for injured participants. Compensation On 30 January 2013, India's Ministry of Health issued final regulations governing compensation for clinical trial injury or death, roughly a year after the draft regulations were released for public comment.  ...
  • Indian Regulators Release Draft Clinical Trial Rules

    India's Ministry of Health has released three new draft rules governing the approval of clinical trials in India , the registration of ethics committees in charge of reviewing and approving investigation protocols and the compensation payable to patients enrolled in clinical trials in the case of injury or death. Clinical trials must first be registered with India's Clinical Trial Registry before patient enrollment can proceed.  The trial sponsor or clinical tr...
  • IFPMA Releases Updated Code of Ethics for Industry

    The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released an updated code of ethics 1 March that aims to broaden the scope of its code of practice to include "interactions with healthcare professionals, medical institutions and patient organizations." "IFPMA requires all member companies and member associations around the world to adopt and implement this new Code," the organization said in a statement. IFPMA counts most of the w...
  • Saudi FDA Draws up Pharmaceutical Code For Pharma Manufacturers, Marketers

    • 01 February 2012
    The Saudi Food and Drug Administration (SFDA) announced that it is releasing a code of ethics applicable for pharmaceutical manufacturers and marketers operating in the Kingdom of Saudi Arabia, reports Arab News . The code, announced in Riyadh on 30 January, "will cover all those who deal with pharmaceutical products in the public and the private sectors," said SFDA Vice Chairman for medicines Saleh Al-Bawazeer. The code is expansive, covering both industry and car...