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San Diego, CA10/17/2017 - 10/18/2017
RAPS Virtual Career Fairs are designed to connect employees with employers no matter where they might be located.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
Regulatory Exchange, aka RegEx, is where members come online to learn, grow and engage with a diverse global community of regulatory professionals with similar interests and goals.
It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.
A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.
The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance.
Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features, US, FDA
Tags: eCTD, Electronic Common Technical Document
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Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month. View More
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. View More
The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology. View More
The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA. View More