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  • Feature ArticlesFeature Articles

    FDA Regulation of Healthcare Product Advertising on Social Media

    Social media offers exciting new approaches to marketing products, but the medical products industry has been slow to participate. Social media communications can be daunting for many reasons: it is public, continuous, interactive and global, and there are often extreme space limitations. Many in the medical device industry point to a lack of US Food and Drug Administration (FDA) guidance 1 as one of the main reasons for caution. In a survey by Massachusetts trade asso...
  • Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

    The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical industry, including advertising through social media channels, according to a 10 October posting in the Federal Register . "FDA has an interest in determining the attitudes, perceptions, and opinions of healthcare professionals with prescribing authority regarding such...
  • FDA Guidance Establishes Specific Recommendations for Ear Infection Therapies

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to assist sponsors developing therapies to treat bacterial ear infections. The guidance, Acute Bacterial Otitis Media (ABOM): Developing Drugs for Treatment , finalizes the draft version of the same guidance, which was released in January 2008, and revised a 1998 guidance by a similar name. "This guidance focuses on specific drug development and trial design issues that are un...
  • FDA Backs HIV Prevention Drug In Letter Denying Citizen Petition

    The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...
  • Clock Starts Ticking on Issuance of FDA's Social Media Guidance

    The end is near-for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is. Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014. "Not later than 2 years aft...
  • J&J Warns Physicians About Counterfeit Medical Device

    • 14 June 2012
    Life sciences manufacturer Johnson & Johnson's subsidiary Ethicon this week warned physicians about counterfeit copies of its Ligaclip Extra Ligating Clip Cartridges, which are used for tubal ligation. The company explained in a "Dear Healthcare Provider Letter" that its investigators had discovered counterfeit copies of the device in at least two countries-the US and Hong Kong-and the company was working with regulatory authorities in both countries to track the sou...
  • 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 ...
  • Generic Boniva Approved, Marking Next Big Patent Expiry

    The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year. The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug. Boniva h...
  • 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...