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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.
Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
RAPS has revealed the names of the six outstanding senior regulatory professionals who will join the elite group of RAPS Fellows in 2017.
This article discusses the evolution, potential uses and regulatory aspects of gene therapy and includes funding, delivery mechanisms, bioethics and steps toward clinical trial implementation.
Categories: Biologics and biotechnology, Human cell and tissue, Features, US, FDA
Tags: Gene therapy,
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. View More
The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs. View More
Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that "computes health data." View More
Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. View More