The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

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

 
  • Regulatory NewsRegulatory News

    WHO Lays Out Five-Year Regulatory Action Plan

    As part of efforts to increase access to quality medical products around the globe, the World Health Organization (WHO) this month crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges. According to WHO surveys, only 30% of NRAs in 2018 had the capacity to effectively and efficiently regulate medical products, although there was greater capacity to regulate...
  • Regulatory NewsRegulatory News

    Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

    The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa. As part of the project, WHO, GlaxoSmithKline, the developer of the vaccine, and the nonprofit PATH will collaborate to donate doses of the vaccine candidate, known as RTS,S, for use in the WHO pilots. In addition to the Gavi funds, WHO will provide about $17 ...
  • Regulatory NewsRegulatory News

    FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews

    The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016. The new rate is about $200,000 more than last year's rate , but more than $2m less than the rate for fiscal year 2012. Back in 2008, FDA issued guidance for industry on tropical disease priority review, detailing the way in which the vouchers can be sol...
  • Regulatory NewsRegulatory News

    Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

    Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization. In fact, EMA's recommendation only applies to regions outside the EU. Instead, the World Health Organization (WHO) and other non-EU regulators will review EMA's recommendation and make a determination on the vaccine's use. Mosquirix The va...
  • Feature ArticlesFeature Articles

    DSHEA: Preserving Legal Access to Chinese Herbal Medicine or Researching new Remedies for Malaria and Other Tropical Diseases

    This article explores the importance of continued access by researchers to Chinese medicinal herbs via DSHEA, in light of a potential increase in tropical diseases in historically non-tropical regions. Preserving access to traditional Chinese medicine will become important as tropical diseases gradually become endemic to the United States. As the climate warms 1 and mosquitos proliferate, 2 diseases formerly confined to the tropics are moving north. 3 Si...
  • Regulatory NewsRegulatory News

    From Gatekeeper to Facilitator: MHRA Touts Innovation Efforts

    Regulatory agencies are often seen by industry as gatekeepers, preventing products from reaching market until after they pass rigorous trials. But in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to position itself as something else, in part: a facilitator. An example is a new case study issued by MHRA in which the agency describes how it was able to help bring a novel vaccine delivery mechanism developed by the University of Oxfo...
  • US Blood Donation Process to Become Easier for Recent Travelers to Cancun, Cozumel

    Malaria-a mosquito-borne disease common in some developing countries that kills hundreds of thousands of people each year-is a serious threat to the health of even healthy humans. But as a new guidance document released on 19 August 2013 by the US Food and Drug Administration (FDA) notes, the disease isn't just confined to the developing world. There is a risk, albeit a small one, of malaria being transmitted during blood transfusions-a risk FDA believes is no longer refl...
  • Malaria Drug Given Boxed Warning by FDA in Light of Side Effects, Link to Massacre

    US regulators have issued a warning regarding the safety of the drug mefloquine hydrochloride, an antimalarial drug widely given to US soldiers and other citizens traveling abroad, saying the drug is associated with a risk of serious psychiatric and nerve side effects. Background The drug has notably been associated with the case of US Army Staff Sgt. Robet Bales , now accused of killing 16 Afghani civilians during a "rampage" in 2012. An adverse event report submitt...
  • New Device Aims to Secure Domestic, Foreign Supply Chain by Identifying Counterfeits

    A new tool unveiled Thursday by US regulators on the eve of world malaria day promises to assist global public health officials with the detection and removal of counterfeit anti-malarial drugs, the likes of which now contribute to a budding public health crisis. Basics: The CD-3 The device, known as the Counterfeit Detection Device v.3 (CD-3), was developed by the US Food and Drug Administration (FDA) with support from the Skoll Global Threats Fund, the US Pharmacopeia...
  • FDA Releases Draft Guidance Changing Blood Donation Criteria

    The US Food and Drug Administration (FDA) has released new draft guidance intended to reduce the risk of transmitting malaria through donated blood. In its 6 June Federal Register posting, FDA said the draft guidance document addresses donor testing, as well as managing donor deferrals and reentry into the pool of blood donors. The purpose of the draft guidance is to "reduce the risk of transfusion-transmitted malaria," FDA wrote in the posting. "This draft guidance d...
  • Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

    • 22 May 2012
    • By
    An article published in The Lancet Infectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate packaging or veracity. The National Institutes of Health (NIH)-funded study looked at 1,437 samples of malaria drugs from seven Asian countries and 2,634 malaria drugs from 21 countries in sub-Saharan Africa. Of the samples obtained from the Asian countries, roughly 33%...
  • Feature ArticlesFeature Articles

    Bloodletting and Malariatherapy: Treatment Methods of the Past

    • 26 April 2012
    • By
    Those interested in the history of medicine should read the details surrounding the therapy rendered to President George Washington by his physicians in December 1799. 1 Purging, bloodletting and other methods were employed, which hastened his death. His treatment was also discussed recently in the New England Journal of Medicine 's 200 th Anniversary issue. 2 The authors used Washington's experience as a benchmark for measuring the remarkable progress medicine has ...