• Regulatory NewsRegulatory News

    FDA Grapples With Lesser-Known Costs of Clinical Trials Transparency

    US medical device regulators soon plan to hold a public hearing to discuss how the results of cardiovascular outcomes trials (CVOTs) can be kept confidential until they are completed. Background The meeting, previewed by the US Food and Drug Administration (FDA) in a 14 July 2014 Federal Register notice, comes after years of the agency placing more of an emphasis on mandatory post-market approval trials. Those trials are meant to assuage outstanding regulatory concer...
  • Regulatory NewsRegulatory News

    EMA Prepares to Free up Clinical Trials Results Starting Next Month

    In less than a month, pharmaceutical companies operating in the EU will need to begin posting clinical trial results in the European Clinical Trials Database (EudraCT) under a new plan meant to expand the amount of information available to consumers. Background The plan was first announced by the European Medicines Agency (EMA) in October 2013, when it said that an update to EudraCT, dubbed EudraCT V9, would enable pharmaceutical companies to post new types of...
  • Regulatory NewsRegulatory News

    EMA Adopts Changes to Trials Transparency Policy, October 2014 Start Date Predicted

    The European Medicines Agency's (EMA) management board has signed off on the regulator's clinical trials transparency policy, adopting several changes along the way the regulator said would make the data the policy is intended to provide access to "more user-friendly." Background As Focus explained earlier this week , EMA has for years been seeking a policy by which it could release patient-anonymized clinical trials data used to support drug approvals to the p...
  • 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
    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...