• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...
  • Regulatory NewsRegulatory News

    FDA Transparency: Gottlieb Outlines What’s Coming

    FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum. On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of t...
  • Regulatory NewsRegulatory News

    States Take on Drug Price Transparency, Gouging

    As the US Congress continues to highlight specific drug price increases rather than adopt wide-reaching legislation to curb such practices, states are taking the matter into their own hands. In California, an Assembly committee on Wednesday moved forward a bill ( SB 17 ) that would shine a spotlight on what the state spends on the most expensive prescription drugs, as well as which drugs have seen the highest year-over-year spending increases. The bill, which pa...
  • Regulatory NewsRegulatory News

    EMA Seeks Experts on Clinical Data Anonymization

    The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data. "Anonymisation of clinical reports poses a major challenge to those directly involved (pharmaceutical industry, clinical research organizations and EMA) and to those accessing the data (patients, healthcare professionals and academia)," EMA says. Specifically, EMA says it plans to form a new committee, referred to as the Techni...
  • Regulatory NewsRegulatory News

    FDA Transparency: Agency’s Hands Tied by its own Regulations

    Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality. And in some areas, like with CRLs, which are letters sent by FDA when medical product applications cannot be approved, research fr...
  • Regulatory NewsRegulatory News

    Maryland Goes a Step Further to Rein in Drug Price Spikes

    A Maryland bill to shine more light on prescription drug prices takes the standard for state transparency efforts a step further by not only requiring pharmaceutical companies to offer a peek into their innerworkings but requires annual reports to be audited by third parties. The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs as ot...
  • Regulatory NewsRegulatory News

    Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports

    Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports. In an article published in JAMA on Monday, Anna Davis and James Miller of Johns Hopkins Bloomberg School of Public Health say that FDA's position as the global leader in drug regulation "may be undermined" if it is not able to match EMA's efforts. "The proactive publication of clinical study rep...
  • Regulatory NewsRegulatory News

    Transparency Push: EMA to Revise Policy on Document Access

    The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals. Since October 2016, EMA has published pharmaceutical trial data via its new website , including for: Mylan's aripiprazole, published most recently on 31 January 2017, Pfizer subsidiary Hospira's palonosetron, Praxbind  (idarucizumab), Tarcev...
  • Regulatory NewsRegulatory News

    EMA Board Signs Off on 2017 Budget as Brexit Questions Linger

    The European Medicines Agency (EMA) on Monday announced that its management board signed off on a slightly increased 2017 budget as preparations for the UK’s departure from the EU continue. “The extent of the impact of Brexit on the Agency’s operations and location is uncertain and will depend on the future relationship between the EU and the UK,” EMA said. “Depending on the outcome of the negotiations, this could cause significant disruption to the Agency’s operations ...
  • Regulatory NewsRegulatory News

    EMA Revises Clinical Data Publication Guidance, Updates on Program

    The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October . Revised Guidance The revision updates the previous version released in March , which clarified the agency's expectations for the data required to submit for publishing under the agency's clinical trial transparency rules. EMA says it has updated the section on the guidance's sc...
  • Regulatory NewsRegulatory News

    Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes

    Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes. This month, Vermont released the first of the reports required under the law , calling into question price hikes from large brand name companies, including Amgen, Mylan, Abbott and Takeda, and generic drugmakers including Perrigo and a private company called Mutual Pharmaceutical Comp...
  • Regulatory NewsRegulatory News

    EMA Transparency: New Clinical Reports Go Live

    The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a new online database. "Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based," said EMA Executive Director Guido Rasi, adding that the initiative "will benef...