In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...

RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...

Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...

When the US Food and Drug Administration (FDA) has significant questions or concerns about clinical data submitted in support of a product under review, it often seeks input from independent academicians and clinicians outside the agency. For this reason, FDA has established Advisory Committees comprised of such experts in various therapeutic areas. Currently, there are 49 such standing committees. If your company is a sponsor of a product subject to Advisory Committee rev...

RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs , the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products. First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration (FDA) and other US agen...

RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...

RAPS’ signature annual event, the Regulatory Convergence , is a unique opportunity for the regulatory community to gather, reconnect, examine important issues together and exchange ideas face-to-face in a setting completely dedicated to the profession. It is the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space. For many, it is the one event they prioritize above all others to attend each year. This year...

A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios. By passing, each of the 235 professionals now hold ...

The European Medicines Agency (EMA) on Wednesday launched a six-month public consultation on its proposed strategy for regulatory science through 2025 following two recent multi-stakeholder workshops on the topic.   “The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said EMA Executive Director Guido Rasi, adding that the agency developed the plan with input from t...

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world. “The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday. She noted that regulators arou...

Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Scales Back Medium-Priority Activities as Brexit Bites   The European Medicines Agency (EMA) has scaled back certain medium-priority activities to offset the effect of Brexit on its capacity. EMA is further pulling back from international collaborations and suspending certain types of meeting until at least 30 June.   EMA triggered the changes by initiating ...

Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   MHRA Extends EpiPen Expiry Dates to Mitigate Supply Shortages   MHRA has allowed Mylan to extend the expiry dates on certain lots of EpiPen to mitigate supply constraints. The organizations think delaying the expiry of nine lots of the adrenaline auto‐injectors by four months will help ensure patients can access the products while Mylan stabilizes supply.   The ...