RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

    New legislation introduced in the US House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill patients. Overview and Background The bill, H.R. 4475, the Compassionate Freedom of Choice Act of 2014, comes in the midst of a long-running debate over whether current regulatory structures-and in particular FDA's Compassionate Use exemption process -is sufficient to treat termi...
  • UK Formally Launches Early Access Pathway for Neediest Patients

    The UK's Medicines and Healthcare products Agency (MHRA) has announced that it had formally opened a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. Background The program, known as the Early Access to Medicines Scheme (EAMS), was first announced in March 2014. As described by the UK's Department of Health, EAMS is intended to make the UK "one of the best countries in the world to capitalize on breakthr...
  • Data Show Varied Use, Success of FDA's Expanded Access Program

    In recent years, much attention has been focused on the pharmaceutical industry and its use-and non-use-of the US Food and Drug Administration's (FDA) expanded access program. But how much success has it had? Background That program, sometimes referred to as the "compassionate use" program, allows patients to access experimental treatments they might otherwise not be eligible to receive. For a full explanation of the program, please see our Regulatory Explainer on ...
  • EMA Unveils New Adaptive Licensing Initiative, Meant to Provide Earlier Niche Approvals

    The European Medicines Agency (EMA) has announced that it will be launching what it's billing as an "adaptive licensing pilot project," an initiative intended to grant earlier access to medicines meant to treat unmet needs. Unlike the US' accelerated approval pathway, which grants a tentative but wide-ranging approval to a product based on interim data, EMA's adaptive licensing framework calls for the authorization of medicines for restricted (i.e. niche) patient populat...
  • MHRA Launches its Own 'Breakthrough' Pathway to Allow for Early Access to Some Medicines

    The UK's Medicines and Healthcare Products Agency (MHRA) has announced that it will soon launch a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. The program, known as the Early Access to Medicines Scheme (EAMS), has long been in the works at the regulator, and its launch was previewed last week in British newspaper The Telegraph . As announced on 14 March 2014 by MHRA and the UK Department of Hea...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program

    Regulatory Focus'  ongoing series of  Regulatory Explainers  wants to take complicated regulatory topics and make them simple for anyone to understand. In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work. Updated 4 February 2015. What's a Compassionate Use Program? Let's back up for a quick moment: Under current US Food and Drug Administration (FDA) regulations, ...
  • New Draft Guidance Establishes Special Controls for Blood Access Devices

    The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis. In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis , which it said serves "as the special control for implanted blood access devices." The draft guidance follows another Federal...
  • Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

    A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June. A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the d...
  • Brazil: Anivsa Sets Confidentiality Criteria

    A notice ( Ordinance No. 748-B/2012 ) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access to Information Act, which recently went into effect.  Examples of what would be classified as non-releasable is information relating to: scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as con...
  • Brazil: Anivsa Implements Freedom of Information Law

    Greater transparency is an integral part of the reorganization of Brazil's national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its possession, other than those classified as confidential.  The Access to Information Law (Law No. 12.527/2011) establishes as a fundamental principle the constitutional right of public access to public information.  The Law is now in effect according to the ordinance ...
  • Group Calls for EU Pharmacovigilance Regulations to Cover Unlicensed Medications

    A coalition of patient groups is calling for the inclusion of unlicensed medication in the next version of the Pharmacovigilance Directive , reports The Pharma Times . The call, led by the European Alliance for Access to Safe Medicines (EAASM), is in response to reports of adverse events occurring with off-label drugs, including Avastin (bevacizumab). "The Alliance says urgent action is needed to address patient safety issues around the use of unlicensed and off-label...
  • Following US, Canada Permits Unapproved Drugs Into Country To Ease Shortages

    Health Canada is allowing unapproved drugs into the country on a short-term, controlled basis in order to alleviate recent drug shortages, reports The Ottawa Citizen . "Under the special access program, the federal drug regulator has the power to grant the limited sale of unapproved drugs to physicians treating select patients with 'serious or life-threatening conditions,'" wrote The Ottawa Citizen . Health Canada has reportedly approved 17 requests under the special...