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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.
The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.
Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel.
This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges.
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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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
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten. 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