• 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

    EMA Revises Guidance on Developing New TB Medicines

    The European Medicines Agency (EMA) on Monday launched a public consultation on revised guidance for companies developing new drugs to treat tuberculosis (TB). Comments on the guidance, which is an addendum to EMA’s guideline on the evaluation of medicines to treat bacterial infections, will be accepted until 31 January 2017. Background TB, caused by a bacterium called Mycobacterium tuberculosis , affects 340,000 new people annually in the EU, and in 2014, 33,000 dea...
  • Regulatory NewsRegulatory News

    Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries

    Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program. Background Article 58 of Regulation (EC) No 726/2004, introduced first in 2004, allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with ...
  • Feature ArticlesFeature Articles

    Bacillus Calmette-Guerin--Another Surprise!

    • 19 October 2012
    After a physical several years ago, my wife learned that red and white blood cells were detected in her urine. The doctor ordered an intravenous pyelogram to determine the cause. In this test, an iodine-containing contrast material is injected into the bloodstream and a series of X-rays are then taken at timed intervals. The resulting films allow the radiologist to view the entire urinary tract. Unfortunately, the diagnosis revealed evidence of bladder cancer, a well-di...
  • FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

    The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes will streamline the clearance pathway for medical devices. "Currently, these tests are Class III (high-risk) devices that require the more rigorous pre-market approval application," said FDA in a statement released on their website 16 March 2012. FDA is proposing to downclass...