RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 

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    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom and Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Pot...
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    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
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    The Essential List of Regulatory Authorities in Europe

    To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list is organized by regional affiliation with the European Union (EU), European Free Trade Association (EFTA) and other European countries. For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the informatio...
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    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
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    FDA Advisory Committee Calendar

    Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   13 September – Allergenic Products Advisory Committee   The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Ai...
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    Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

    With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written. (Editor’s Note: This is by no means a complete list and if you’re looking for more than 85 accounts, you’re in...
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    The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

    Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost encyclopedic knowledge of the regulator's website to find relevant information, to say nothing of the dozens of other government websites which house regulatory information or non-governmental websites which make finding information easier. What if there were an easier way t...
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    India's Data Integrity Problems

    In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities. Those data are intended to ensure that products meet pre-established specifications, such as for purity, potency, stability and sterility. In the absence of credible data, the concern is that these products cannot be trusted. And indeed, FDA has subject many...
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    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
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    9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

    It can be profoundly difficult to monitor—let alone make sense of—the regulatory affairs environment. Thanks to constantly changing laws, regulations, policies, legal developments, technologies and sources of information, regulatory professionals need all the help they can get to conduct regulatory surveillance. Luckily, even for regulatory professionals without a budget, there are several free tools and websites that can help you find information, stay ahead of your pee...
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    Using RSS Feeds as a Regulatory Intelligence Tool: The (Updated List of) Feeds you Need to Follow

    Which websites should regulatory professionals be reading, and how should they be reading them? For regulatory professionals—and especially those involved in regulatory intelligence—staying current with the latest information is a constant struggle. And while each professional's list of required reading sources may differ significantly, all regulatory professionals could stand to benefit from taking advantage of a technology platform known as RSS (Really Simple Syndica...