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  • 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

    Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

    The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates. FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installa...
  • Regulatory NewsRegulatory News

    Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics

    The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos. The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member...
  • Regulatory NewsRegulatory News

    MSF: Access to New TB Medicines Falters Despite Conditional Approvals

    Doctors without Borders (MSF) released a new report on Monday offering details on how the first new drugs in nearly half a century were conditionally approved to treat tuberculosis (TB),  though only 2% of the roughly 150,000 who could benefit from these treatments have access to them. The report comes as the World Health Organization (WHO) reports that only half of notified multi-drug-resistant tuberculosis (MDR-TB) patients were successfully treated and cured in 2014 ...
  • FDA Draft Guidance on Pulmonary TB Seeks to Confront Drug Development Challenges

    The US Food and Drug Administration (FDA) this week released a new draft guidance on the development of new drugs intended to treat pulmonary tuberculosis (TB), a bacterially-transmitted disease that has seen increasing rates of drug resistance in recent years. In a Federal Register announcement on the release of the draft guidance, FDA said its release was driven by three treatment challenges: increasing rates of antibiotic resistance, existing drugs interact poorly w...
  • Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

    Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...
  • US Regulators Debar Man for Marketing Unapproved Products

    The US Food and Drug Administration (FDA) has issued a debarment order against a man convicted of introducing two pharmaceutical products into interstate commerce in violation of federal law after he claimed his unapproved products could treat a range of ailments including cystic fibrosis, SARS and tuberculosis. In its 29 June 2012 Federal Register posting, FDA recounted what it called the "factual basis" for its debarment order, starting with a warning letter sent to ...
  • 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...