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  • EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies

    The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...
  • Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

    • 18 October 2012
    Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals. The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the am...
  • NIH Initiative Hopes to Improve How Preclinical Testing is Reported

    • 11 October 2012
    The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them easier to reproduce and understand. The problem, explains NIH, is the gap between conducting animal studies and being able to study the effect of a drug in human trials. "Positive results from animal studies are sometimes difficult to translate into successful clinical trials,...
  • FDA Given New Authority to Oversee Clinical Trials Data Reporting

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement . Under section 801 of the Public Health Service Act (PHSA) , as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institut...
  • Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

    • 24 September 2012
    Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor. In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administrat...
  • Proposed Changes to Antibiotic Regulation Given More Time for Public Comment

    The US Food and Drug Administration (FDA) has extended the amount of time the public and members of industry may comment on an advanced notice of public rulemaking concerning proposed changes to the way the agency collects and tracks information about antibiotics. The regulation regards authority given to the agency under the Animal Drug User Fee Amendments Act of 2008 ( AGDUFA ), which allows FDA to require sponsors to submit annual reports detailing sales, distributi...
  • AHRQ Plans Patient-Based Adverse Event Reporting System

    • 12 September 2012
    Adverse event reporting could become more widespread under a new system proposed by the Agency for Healthcare Research and Quality (AHRQ). In a 10 September Federal Register posting , the agency, which acts to collect and analyze data about the quality and efficiency of care in the US, said it had submitted to the Office of Management and budget (OMB) a request to approve its prototype for a Consumer Reporting System for Patient Safety Events. AHRQ said the system is...
  • GHTF Releases Adverse Event Report Standard for Pre-Clinical Trials

    The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final document on its SG5:N5:2012 clinical trials adverse event reporting standard. The standard, Reportable Events During Pre-Market Clinical Investigations , released 10 August 2012, is the product of GHTF's Study Group 5 (SG5) -a group charged with harmonizing clinical safety...
  • EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

    The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators. The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection ...
  • Warning Letter Analysis: Siemens, Terumo Cited for Adulterated Devices

    • 20 June 2012
    The US Food and Drug Administration (FDA) sent warning letters in May 2012 to Siemens Healthcare Diagnostics, Inc and Terumo Medical Products Hangzhou Company Ltd accusing the companies of manufacturing adulterated products in violation of federally mandated Quality System Regulations (QSRs). For one of the companies, the warning letter effectively bars its products from being imported into the US. Siemens Healthcare Diagnostics, Inc. (Medical Device) In its 10 May ...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...
  • China: 2011 Adverse Reaction Report Released

    China's State Food and Drug Administration (SFDA) has released a report detailing the adverse event reports it received during 2011. The report notes events involving anti-infective medicines accounted for the higher number of reports, including cephalosporins (34.8%), penicillin (14%) and quinolones (12.2%). New and serious adverse drug reactions accounted for 17.1% of the total number of reports.  Medical institutions were the primary source for such reports, acco...