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Online1/4/2017 - 4/13/2017
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.
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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The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs. View More
President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA). View More
In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Monday that his administration will be “cutting regulations at a level no one has ever seen before.” View More
The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). View More