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  • 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...
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    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...
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    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...
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    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...
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    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...
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    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 ...
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    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...
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    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...
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    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...
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    EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts

    The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation. The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provid...
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    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
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    New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10%

    US Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ), as well as Rep. Jan Schakowsky (D-IL), on Thursday introduced new bills that would require drug manufacturers to disclose and provide more information about planned drug price increases, including research and development costs. More specifically, the  FAIR Drug Pricing Act  would require drug manufacturers to notify the US Department of Health and Human Services (HHS) and submit a transparency and justification...