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  • Regulatory NewsRegulatory News

    FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

    The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the tre...
  • Regulatory NewsRegulatory News

    FDA Launches Expanded Access Pilot ‘Project Facilitate’

    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.   “The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not fami...
  • Regulatory NewsRegulatory News

    EMA to Continue Adaptive Pathways Program as Pilot Ends

    The European Medicines Agency (EMA) on Wednesday published a final report on its experience from its adaptive pathways pilot project, noting that a few aspects of the program need to be further improved and refined moving forward.  Though the vast majority of applications for the pilot were rejected, EMA said that moving forward, the agency needs to further integrate the patient voice into the program and refine the definition of methodologically sound strategies for col...
  • Regulatory NewsRegulatory News

    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
  • Regulatory NewsRegulatory News

    EMA to Continue Parallel Scientific, HTA Advice Following Successful Pilot

    The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs. Due to the success of the pilot, which concluded on Wednesday, EMA says it will continue to offer parallel scientific advice as part of its routine activities. "Our parallel scientific advice fosters...
  • Regulatory NewsRegulatory News

    FDA Plans Pilot Project on Clinical Outcome Assessments

    As part of the US Food and Drug Administration’s (FDA) work on patient-focused drug development, the agency is launching a pilot project where it will collate and summarize clinical outcomes on a number of different diseases in one online resource. The clinical outcome assessment (COA) pilot project, announced Wednesday, is intended to be a starting point for companies considering how certain COAs might be used in clinical trials and early drug development. COAs for th...
  • 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...
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    How Does the Pharmaceutical Industry Really Work? FDA Wants its Managers to Know

    The Center for Drug Evaluation and Research (CDER) has announced that it plans to continue a program which allows pharmaceutical companies to invite regulators to visit their manufacturing sites to better understand how the industry operates. Background The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the "Site Tours" program, has been in effect in various forms since 1999, when it was created by CDER's Training a...
  • Regulatory NewsRegulatory News

    DOD Steps Onto FDA Turf, Seeking to Evaluate Safety and Effectiveness of LDTs

    The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...
  • Feature ArticlesFeature Articles

    Project Teams for Regulatory Advisory Committees

    Imagine the end of a voyage. The ship bobs a few feet from the dock. A crowd awaits cargo, and everyone aboard yearns for shore. Now imagine the decision about whether the journey is ended is not yours to make. Imagine you must argue publicly the merits of your journey and the status of your cargo. Your debate is not with those on the journey or those met en route, but with experts on journeys and cargo. They vote after discussion. Everyone waits, on both sides of the doc...
  • FDA to Continue Regulatory Training Program That Brings Together Regulators and Industry

    US pharmaceutical regulators have announced that they will continue a regulatory program that allows companies to invite officials from the Center for Drug Evaluation and Research (CDER) into their facilities to learn more about how the industry works. Background: Site Tours Program The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999 when it was c...
  • Report: Phase III Clinical Trials Behind Increase in the Cost of Pharmaceuticals

    The US Food and Drug Administration's (FDA) insistence that pharmaceutical manufacturers take their products through extensive-and expensive-testing is driving up the price of drugs and the stakes of failure for companies. That's the conclusion of a new paper from Avik S.A. Roy, a senior fellow at the Manhattan Institute for Policy Research, entitled "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials."  Roy cites the dramatic rise in the cost to res...