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  • Regulatory NewsRegulatory News

    EU Adaptive Licensing Program Moves Forward, With More Clarity for Sponsors

    The European Medicines Agency (EMA) wants to make it easier for companies to use its adaptive licensing pilot program, a new effort to grant accelerated access to medicines intended for limited populations of patients with serious unmet medical needs. Background The adaptive licensing pilot program was first announced in March 2014, and is an attempt to move beyond clear-cut yes-or-no approval dichotomies, and to instead allow some drugs to be approved for limited pop...
  • Regulatory NewsRegulatory News

    FDA Review Finds Storage Problems at Food, Supplement Regulator CFSAN

    The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus. Background In July 2014, FDA and the National Institutes of Health (NIH) announced they had discovered previously unknown vials containing variola—the virus which causes smallpox—as well...
  • Regulatory NewsRegulatory News

    Pfizer Launches Expanded Access Program for Breast Cancer Drug

    The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly differen...
  • Regulatory NewsRegulatory News

    New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple

    A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance. CDRH Submission Tracker Pilot The Center for Devices and Radiological Health's (CDRH) pilot program, known as the CDRH Submission Tracker pilot, is an attempt to allow companies large and small to have a better sense of...
  • Regulatory NewsRegulatory News

    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
  • Regulatory NewsRegulatory News

    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...
  • Regulatory NewsRegulatory News

    Head of FDA's Rare Disease Division Departs, Leaving Agency Looking for New Leader

    The US Food and Drug Administration (FDA) is looking for a new leader for its Rare Diseases Program. In an email to staff on 16 July 2014, John Jenkins, director of the Office of New Drugs (OND), which oversees the rare disease program, said the program's current leader would be transitioning to a new role at FDA. Anne Pariser, OND associate director for rare diseases, will take on a new position in the Office of Translational Sciences, Jenkins said. Pariser will still ...
  • Regulatory NewsRegulatory News

    FDA Planning Five Guidance Documents to Help Children With Rare Diseases

    • 10 July 2014
    The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD). The report, Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases , was required under Section 510 of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) and based off a...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • Regulatory NewsRegulatory News

    EMA Adaptive Licensing Project Moves Forward, Two Candidates in Tow

    In March 2014, the European Medicines Agency (EMA) announced that it would soon launch a new pilot program intended to grant "adaptive licenses" to medicines, permitting patients with unmet needs to access the medicines far earlier than they would otherwise. Now EMA has announced that the program is up and running, and that regulators have already accepted the first two medicines into the program, with another four waiting in the wings. Background EMA's adaptive...
  • Regulatory NewsRegulatory News

    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...
  • New 510(k) Pilot Program Aims to Take the Frustration out of Submissions

    Each year in the US, millions of Americans choose to utilize the services of an online tax preparation service like TurboTax, H&R Block, TaxACT and others. The Internal Revenue Service (IRS) has also gotten into the business of making it easier to file with its own Free File Software , available to consumers making less than a certain income. Despite its cost, the software is popular because it makes filing taxes-ordinarily a time-consuming, confusing and otherwise ...