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  • Regulatory NewsRegulatory News

    This Week in Medical Device Regulation (10-14 November 2014)

    • 16 November 2014
    Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence. Regulatory Focus FDA Authorizes Sixth Device to Help in Fight Against Ebola ( Regulatory Focus ) FDA Provides Some Clarity to Complex Regulatory Environment for Molecular Diagnostics ( Regulatory Focus ) Major Changes to Medical Device Registration Process in Japan ( Regulatory Focus ) US: Medical Devices FDA's Gutierrez clarifies LDT...
  • Regulatory NewsRegulatory News

    This Week in Medical Device Regulation (3-7 November 2014)

    Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence. Regulatory Focus: FDA Will Soon Need to Publish More Information About the Outside Standards it Uses ( Regulatory Focus ) FDA Looking for a Leader for its New Device Testing Division ( Regulatory Focus ) Is FDA Listening Enough to Patients? Agency Wants Feedback ( Regulatory Focus ) ANVISA Allowing Automatic Deadline Extensions for Medical Device Regist...
  • Regulatory NewsRegulatory News

    This Week in Pharmaceutical Regulation (3-7 November 2014)

    Welcome to This Week in Pharmaceutical Regulation, your weekly review of regulatory news and intelligence. Regulatory Focus: Is FDA Listening Enough to Patients? Agency Wants Feedback ( Regulatory Focus ) Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster ( Regulatory Focus ) FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny ( Regulatory Focus ) In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims ( Regulator...
  • Regulatory NewsRegulatory News

    It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...
  • Regulatory NewsRegulatory News

    Europe Establishes Roadmap for Companies Hoping to Get Ebola Treatments Approved

    The European Medicines Agency (EMA)—Europe's equivalent to the US Food and Drug Administration (FDA)—says it stands ready, willing and able to help accelerate the evaluation of new medicines and vaccines meant to treat a global outbreak of the Ebola virus. Earlier this week, the agency said it was encouraging companies to apply for orphan designation for their products—a designation intended to accelerate the review of products by allowing companies to access thorough sc...
  • Regulatory NewsRegulatory News

    Public View of FDA Continues to Improve in New Poll

    More than half of the US public believes that the US Food and Drug Administration (FDA) is doing a good or excellent job, according to a recent survey sponsored by the pro-regulation group Coalition for Sensible Safeguards. The survey, based on a nationwide survey in July 2014 of 700 likely voters from around the country, quizzed respondents on their views of the US government and its many regulatory agencies. Respondents were relatively split on their view of the fe...
  • Regulatory NewsRegulatory News

    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
  • Regulatory NewsRegulatory News

    Can FDA Regulate LDTs Through Guidance? Legal Analysis Casts Doubt

    In recent weeks the US Food and Drug Administration (FDA) has undertaken major steps meant to bring lab-developed tests (LDTs)—devices developed, tested and used within a single laboratory—under stricter regulatory controls. But now new questions are being raised about whether the agency is using the correct methods to enact those changes. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval thro...
  • Regulatory NewsRegulatory News

    One of FDA's Top Device Regulators Stepping Aside

    One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency. In an announcement on 19 August 2014, FDA said that Foreman—now director of the Office of Device Evaluation (ODE), the office which oversees approval of all medical devices in the US—will soon assume a new, as-yet undefined role at FDA's Center for Tobacco Products (CTP). Foreman's last day...
  • Regulatory NewsRegulatory News

    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments

    Unless you've been living under a rock this month, you've undoubtedly heard about a massive outbreak of the Ebola virus in western Africa. The virus is poorly understood, exceedingly rare and, most importantly, incredibly deadly. But what you probably haven't heard about is how treatments for Ebola are regulated—an oversight we at Focus are keen to correct. In this Regulatory Explainer , we're taking a look at the regulations that surround the development of a pote...
  • Regulatory NewsRegulatory News

    In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

    The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...