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Fort Washington, PA1/9/2018
Evanston, IL5/20/2018 - 5/23/2018
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.
When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.
This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable medical device. View More
Almost a year ago, President Donald Trump told pharmaceutical executives that his administration will cut regulations "at a level no one has ever seen before." View More
The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. View More
The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility. View More