• Regulatory NewsRegulatory News

    FDA: US Clinical Research Using Three-Parent Baby Technique is Illegal

    The US Food and Drug Administration (FDA) said Friday that it is illegal to perform research in the US on a new type of technology that showed promise last year in helping a woman who had multiple miscarriages because of a genetic disorder to give birth to a baby boy in Mexico without that disorder. The technology, known as mitochondrial replacement technology (MRT), deals with mitochondrial DNA passed down only from mother to child. In September 2016, MRT was used to...
  • Regulatory NewsRegulatory News

    WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause

    The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus. "I am now declaring that the recent clusters of microcephaly and other neurological abnormalities reported in Latin America, following a similar cluster reported in French Polynesia in 2014 constitutes a Public Health Emergency of International Co...
  • FDA Says Sponsors of Chronic Fatigue Syndrome Drugs can Rely on Patient-Reported Outcomes

    The US Food and Drug Administration (FDA) has released a new draft guidance document intended to expedite the development of drugs to treat chronic fatigue syndrome (also known as myalgic encephalomyelitis)-a poorly understood condition that has recently been subject to significant interest by FDA regulators. Background Chronic fatigue syndrome (CFS) affects patients by causing severe, persistent and often debilitating fatigue. Little is known about the underlying cause...
  • NIH Launches New Registry for Down Syndrome Patients

    • 29 October 2012
    The US National Institutes of Health (NIH) has announced the establishment of a new patient registry for patients with Down syndrome, part of an effort to "facilitate contacts and information sharing among families, patients, researchers and parent groups." The registry could eventually have powerful research applications and regulatory significance. A similar registry operated by the Cystic Fibrosis (CF) foundation has been a driving force in product development, and ...
  • FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs

    The US Food and Drug Administration (FDA) has released final guidance for industry to assist sponsors looking to develop drugs to treat patients suffering from irritable bowel syndrome (IBS). The 30 May guidance, Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment , covers general IBS symptoms and addresses two sub-sets of IBS which primarily result in diarrhea (IBS-D) and constipation (IBS-C), which FDA said have unique consi...