• Threat of Flu Leads FDA to Grant Emergency Use Approval to New Diagnostic Test

    For the third time ever, the US Food and Drug Administration (FDA) has approved a new diagnostic test under "emergency use" provisions granted to it in 2013 under a little-known law. Background In March 2013, the US Food and Drug Administration (FDA) was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a piece of legislation meant to bolster the government's ability to respond ...
  • FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus

    For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an understanding that an emerging virus could become a threat to public health. This time, however, the emerging virus is far different than the typical strains of influenza public health officials usually grapple with. Background In March 2013, the US Food and Drug Administrat...
  • Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies

    The European Commission has launched a consultation on the "situations" in which post-authorization studies would be imposed, something required by the 2010 legislation that revamped the EU pharmacovigilance system. The Commission's reflection paper notes in the section on "Efficacy Versus Effectiveness" that the criteria used by the European Medicines Agency (EMA) for a marketing approval recommendation have been the subject of some debate in recent years.  The...
  • European Legislators Propose Premarket Approval System for Some Medical Devices

    Legislators of the European Parliament (EP) have proposed more stringent safety measures for implantable medical devices, including implant registries, tougher safety inspections, better product traceability and-perhaps most importantly-a premarket authorization system. The proposed changes come after the discovery of widespread quality issues with now-defunct French implant manufacturer Poly Implant Prothese's breast implant products. The products are purported to have ...
  • EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures

    The European Medicines Agency (EMA) has released updated guidance on procedural advice for its post-authorization and pre-authorization procedural advice, providing regulatory professionals with comprehensive and integrated lists of the answers to most questions regarding the authorization procedure. EMA's 26 April guidances cover questions and answers applicable to the pre- and post-submission timeframes, and are frequently updated. Read more: European Medicines A...
  • EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

    The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...
  • EMA, HMA Release Joint Guidance Document on Commercially Confidential Information in MAAs

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced 27 March they have adopted a joint guidance document that will provide a "consistent Europe-wide approach to the identification of commercially confidential information and personal data in a marketing authorization application." "In [the] future, regulatory authorities in the European Economic Area (EEA) will apply the same principles to identify which parts of an application dossier...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...