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    European Regulatory Roundup: MEPs Plan Amsterdam Trip as Parliament Criticizes EMA Move

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   MEPs Plan Amsterdam Fact-Finding Trip as Parliament Steps up Criticism of EMA Move   European politicians are set to visit Amsterdam to check up on the status of the medicine agency’s relocation to the city. The members of the European Parliament (MEPs) see the visit as a chance to confirm if the move is proceeding “as planned and with no interruption” before finalizi...
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    New Developments in Payor Communications: Are 20 Years of Uncertainty Over?

    This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance. Introduction In...
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    FDA Warns Two Cadila Manufacturing Plants in India

    Just before the end of 2015, the US Food and Drug Administration (FDA) warned two Indian pharmaceutical manufacturing facilities from Cadila Healthcare for major good manufacturing practice (GMP) violations. The warning letter (not to be confused with the warning letter for another Indian manufacturer that goes by the name of Cadila Pharmaceuticals) caps a year of increased scrutiny for Indian drug manufacturers from FDA. Letter Details In particular, FDA found tha...
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    FDA to Spend $16M to Track National Prescribing Trends

    The US Food and Drug Administration (FDA) is preparing to put more than $16 million into a multi-year program intended to provide regulators with data on how US patients are prescribed drug products. The data, including medical claims data, is meant to provide regulators with the ability to see which drugs are being used by patients, for how long and with what other drugs. Regulators are also looking to pair that data up with basic demographic data on patients, such as a...
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    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
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    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
  • FDA Finalizes Guidance on 'Dear Healthcare Provider' Letters

    The US Food and Drug Administration (FDA) has released a final guidance that aims to clarify the agency's requirements for information contained within "Dear Healthcare Provider" (DHCP) letters. Background The letters-so-named because they often begin with that exact salutation-are usually bulk mailings sent out by a manufacturer when it has been made aware of a serious problem with a drug or biologic, or when there is a need to provide updated information to the health...
  • Regulatory Reconnaissance (2 August 2013)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance. In Focus: "Would Have Written About These" Highlights BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal ( BIO ) ( BIO ) BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Se...
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    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...
  • 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...
  • 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...
  • 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...