Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions.
Alpharetta, GA4/8/2015 - 4/29/2015
Take 15 minutes to learn how to apply regulatory competency frameworks to your professional development plan with a free webinar from RAPS. From entry level to C-suite executives, RAPS understands the complexity of the regulatory profession and has a free tool to help you build out a roadmap for career success.
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.
Placeholder for Higher Logic Forum Discussions - DO NOT DELETE
overview of expedited pathways for US medical devices that are alternatives to Traditional
510(k)s and Premarket Approval Applications (PMAs). These include Special
510(k), Abbreviated 510(k) and Humanitarian Device Exemption (HDE) submission types.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.
Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.