• Regulatory NewsRegulatory News

    Drug Compounding With Bulk Substances: FDA Offers Interim Policies

    The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs. The policies also clarify that the two guidance documents do not apply to inactive ingredients, which can be used in compounding without appearing on the bulk drug substances lists dev...
  • Regulatory NewsRegulatory News

    Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

    A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards. Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues. In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO ...
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    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...
  • 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...
  • Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results

    • 10 June 2013
    A new piece of legislation introduced in the US House of Representatives last week would require clinical trials to report their results to an existing registry maintained by US officials or risk losing both current and future funding. Background At present, sponsors of clinical trials are responsible for making basic data available to the public through a database maintained by the US Food and Drug Administration ( FDA ) and the National Institutes of Health (NIH) know...
  • MHRA Officials Find Suspect Breast Implant Product Rupturing at Accelerated Rate

    Regulatory officials at the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have released an interim report looking into an implantable medical device that was recently found to be manufactured using sub-standard and unapproved components . MHRA regulators have since 2010 been focused on breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese (PIP), whose products were manufactured with industrial-grade, rather tha...
  • Study of FDA Staff Scientists Finds Lingering Concerns Amidst Improving Outlook

    A study released 7 March by the Union of Concern Scientists (UCS) finds that US Food and Drug Administration (FDA) staff scientists are increasingly upbeat about the direction of the agency. Among the survey's findings : Only 43.5% of staff scientists believes the center or office where they work has the resources it needs to meet its role in fulfilling the mission of FDA Despite a lack of resources, 75% of respondents believe FDA is acting effectively to protect pub...