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  • Regulatory NewsRegulatory News

    EMA Defends Changes to Trials Transparency Plan as Advocates go on Attack

    The European Medicines Agency (EMA) is defending its updated clinical trials transparency policy, now derided by some as ineffectual and contrary to its original aims, as being a "compromise approach" meant to placate concerns within industry that too much transparency would have had detrimental effects. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies we...
  • FDA Offers New Ideas for Transparent Approach Toward Regulatory Enforcement

    Here at Focus , we read regulatory enforcement documents like it's our job. To be fair, understanding what the US Food and Drug Administration (FDA) is doing and why is our job. But despite having read through thousands of Warning Letters, recall notices, Form-483s and other enforcement notices, we can say one thing with relatively certainty: It's never been easy to track down everything FDA does. Information: Hard to Find, Hard to Process Some of its enforcement...
  • EMA Tries to Clamp Down on Revolving Door of Regulators

    EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). While those COIs spanned a wide number of areas, among the most critical identified was the ...
  • EMA Set to Finalize Clinical Trials Transparency Policy

    The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry and European Union (EU) institutions before finalizing its clinical trials transparency policy.  The intent is to "fine tune" specific aspects of the policy, such as the possible redaction of the clinical study reports for those parts of clinical trial data that excep...
  • AbbVie Withdraws Legal Challenge Against EMA Regulatory Transparency Policy

    EU regulators have announced that one of two major legal challenges to a policy that would make public the results of many clinical trials used to support approval of already-approved drug products has been withdrawn. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recall...
  • In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures

    • 02 April 2014
    • By
    The European Parliament (EP) today overwhelmingly passed new rules requiring pharmaceutical companies to make public the results of clinical trials, clearing the way for adoption of the rules in the EU later this year. The 2 April 2014 vote saw approval of the new rules by a margin of 594 in favor to 17 against, with 13 members of parliament abstaining. Background The vote comes after months of extensive debate and numerous delays, reflecting the broad scope of the pas...
  • BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan

    The Biotechnology Industry Organization (BIO) has announced that its member companies will soon grant wider access to clinical data, mirroring recent and similar efforts made by the pharmaceutical industry but falling short of calls made by transparency campaigners. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regardi...
  • FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted

    The US Food and Drug Administration (FDA) has issued a final regulation which it says will allow it to increase the transparency of its veterinary drug approval decisions. The 14 March 2014 announcement in the US Federal Register , a compendium of all regulatory decisions made by US government entities, aims to better work within an unusual statutory confinements. Background When a human pharmaceutical product is approved, the materials used to support its approval ...
  • Study Finds Widespread Problems in Reporting of Clinical Trial Results

    According to a new study published in the Journal of the American Medical Association (JAMA) , the results of clinical trials reported to the public are frequently inaccurate, raising questions about the accuracy of current and future trial transparency efforts. The study, Reporting of Results in ClinicalTrials.gov and High-Impact Journals , looked at 96 different research trial results published in prestigious medical journals (impact factor greater than or equal to 1...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • EMA Shines a Light into its Black Boxes of Regulatory: Its Review Committee Meetings

    US regulatory professionals have long benefited from meeting transcripts and other open meeting requirements that have meant that the inner workings and decisions of the US Food and Drug Administration's (FDA) various advisory committees are available for debate and dissection. Background This can be extremely useful for a range of stakeholders. Regulatory professionals seeking approval for similar products can tailor their applications to address the needs of committee...
  • EMA, Hit by Legal Delays, Says it Plans to Stay the Course on Clinical Trials Transparency

    The European Medicines Agency (EMA) isn't backing down in the face of legal challenges against its plan to publish clinical trial data and continue work on the transparency initiative throughout 2014, it announced Monday. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later re...