• New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance

    A new program announced by the US Food and Drug Administration aims to strengthen global regulatory capacity by working with the World Health Organization (WHO) to support new, innovative approaches to clinical trial designs for vaccine products and postmarketing pharmacovigilance. "Adequate regulatory oversight throughout the vaccine development life cycle is essential in assuring the safety, purity, and potency of vaccines and other biological," said FDA's Center for B...
  • Brazil: House Holds Hearing on Breast Implants

    The Commission on Social Security and Family of the House of Representatives held on 19 April 2012 a public hearing to discuss the situation of Brazilian women with silicone breast implants made by now-defunct French manufacturer Poly Implant Prothese and Dutch manufacturer Rofil.  ANVISA's Chief Executive Officer, Dirceu Barbano, noted his agency had inspected two manufacturers and that by the end of this year all manufacturing plants with valid registration woul...
  • DHHS Looks to Social Media for Warning Signals

    • 22 March 2012
    A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools-specifically the micro-blogging website Twitter-to provide the agency with advanced signals to help identify public health emergencies. In a 20 March press release, DHHS said it is looking for developers to create tools that look at real-time data on public health issues, with a particular focus on illnesses. The agency hopes to develop a tool that will be "useful as ...
  • FTC Considering New Guidance on Social Media, Advertising

    The US Federal Trade Commission (FTC), the governmental body that oversees advertising regulation in the US, is considering new guidance for disclosures in online advertisements, particularly advertisements in social media platforms. FTC will hold a workshop on 30 May to discuss the topic with stakeholders, as well as discuss the possibility of updating existing guidance known as the "Dot Com Disclosures." FTC anticipates discussing: "How can effective disclosures be ...
  • Transparency Task Force Initiative Report Adopted by FDA, Will Explore 8 Initiatives

    An October 2011 report issued by the US Food and Drug Administration's (FDA) Transparency Task Force is being adopted by FDA Commissioner Margaret Hamburg, according to an advance Federal Register notice to be published on 1 February. The Transparency Task Force, part of FDA's Transparency Initiative to increase its accessibility and transparency to the public and industry, re-issued the report on 31 January. The report lists 8 initiatives that FDA can undertak...
  • Proposed FDA Study to Look at DTC Advertising, Social Media

    The US Food and Drug Administration (FDA) announced today that it is planning on conducting a survey of healthcare professionals regarding their opinions and perceptions of prescription drug promotion directed at consumers and healthcare providers. FDA's Federal Register posting notes that consumers and providers alike are subject to direct-to-consumer (DTC) advertising from pharmaceutical companies, and that questions have been raised regarding the influence of these ...