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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 European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.
Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.
Categories: Generic drugs, Regulatory strategy, Submission and registration, Features, US, FDA
Tags: Non-Biological Complex Drugs, NBCD
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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
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
As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. View More
The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. View More