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  • Regulatory NewsRegulatory News

    EU Ombudsman Calls on EMA to Release Redacted Humira Study Data

    The EU Ombudsman is calling for the European Medicines Agency (EMA) to release more information from three clinical trials for one of the most commercially successful drugs of all time, AbbVie's arthritis drug Humira (adalimumab), and says EMA should also make changes to how it handles disclosing information in the future. Specifically, the ombudsman suggests that going forward, EMA should require companies applying for EU marketing authorization to provide the agency wi...
  • Regulatory NewsRegulatory News

    Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes

    Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes. Shumlin said Friday the bill was directed at providing answers on why pharmaceutical companies, like Turing Pharmaceuticals, disproportionately h...
  • Regulatory NewsRegulatory News

    EMA Executive Director: Agency Ready for Challenges Ahead

    The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term. In his first press briefing since being reinstated as Executive Director of EMA in November, Rasi says he sees three major factors that will set the tone during his term. First, Rasi says "our understanding of the human body and the underlying science [of medicine] has vastly grown" in recent years. To meet this chal...
  • Regulatory NewsRegulatory News

    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
  • Regulatory NewsRegulatory News

    EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

    Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...
  • Regulatory NewsRegulatory News

    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
  • Regulatory NewsRegulatory News

    UK Prime Minister Calls for Greater Clinical Trial Transparency in Emergencies

    In response to the shortfalls in the international response to the Ebola outbreak, UK Prime Minister David Cameron is proposing a plan to boost research and transparency in the hopes of better confronting future public health crises. The Plan Cameron, who spent the past two days with other world leaders from Canada, France, Germany, Italy, Japan, the US and EU at the G7 Summit in Germany, said the world must "be far better prepared with better research, more drug develo...
  • Feature ArticlesFeature Articles

    The Untold Compliance Story Behind Sunshine Data

    Under Section 6002 of the Patient Protection and Affordable Care Act (commonly referred to as the Sunshine Act ), data must be reported to the Centers for Medicare and Medicaid Services (CMS) by pharmaceutical and medical device manufacturers regarding promotional, research, consulting and other support activities. 1 These data tell a very public story about those activities and the recipients of any fees or transfers of value behind them. Unfortunately, negative pu...
  • Regulatory NewsRegulatory News

    Company Challenges UK Clinical Trial Transparency Rules

    An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports. Background The Health Research Authority (HRA) is a recently launched branch of the UK's National Health Service (NHS), tasked with overseeing clinical research and making recommendations on how research is regulated. While HRA's main mandate is ...
  • Regulatory NewsRegulatory News

    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    India’s Regulator Talks Improvements

    India’s drug regulator has struggled with criticism from inside and outside the country in recent years, but the agency wants the public to know it is taking steps to improve its performance. CDSCO’s Efforts In a post to its website today, the Central Drugs Standard Control Organization (CDSCO) lists nine areas it has worked on during the previous month. To combat the present outbreak of H1N1, also known as swine flu, CDSCO has taken measures to make sure drugs use...