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Babson Park, MA10/24/2017
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 first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.
The European Medicines Agency (EMA) and European Commission on Friday published a joint action plan to further the development of new cell and gene therapies, as well as other advanced therapy medicinal products (ATMPs).
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency.
Categories: Drugs, Medical Devices, Compliance, Government affairs, Features, US, FDA, Advertising and Promotion
Tags: Office of Prescription Drug Promotion, FDA, draft guidance, social media, drug ads on social media
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The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine), Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib). View More
Republican representatives David Trott (R-MI) and Susan Brooks (R-IN) last week introduced a bill calling for the US Food and Drug Administration (FDA) to lead a new public-private working group on medical device cybersecurity. View More
The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. View More
In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to sell the patents to a Native American tribe. View More