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Regulatory NewsRegulatory News
FDA, EMA officials discuss impediments to cell and gene therapies
Posted 17 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the develop...
RoundupsRoundups
Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback
Posted 17 May 2022 By Nick Paul Taylor
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry feedback on the draft proposal. Medsafe is retaining the proposed 4.2% increase across all fees but making...
ReconRecon
Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio
Posted 17 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints
Posted 17 May 2022 By Jeff Craven
More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal trial, and slightly less than half of pivotal trials supporting novel drug approval used surrogate endpoin...
Regulatory NewsRegulatory News
IVDR: Commission adds risk management standard to harmonized standards list
Posted 16 May 2022 By Michael Mezher
The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
ReconRecon
Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs
Posted 16 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDAThis Week at FDA
Regulatory NewsRegulatory News
This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases
Posted 13 May 2022 By Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we saw legislation to reauthorize the ...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event
Posted 12 May 2022 By Zachary Brousseau
RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years and drew more than 500 participants from six continents and 33 countries.
Virtual Programs Virtual Programs
Preparing to Take the RAC Devices Exam - Oct 2022
Tuesday, 11 October 2022 (5:00 - 8:30PM) 6.0 RAC Credits Members: $580|Non-members: $680
For those preparing to take the RAC Devices exam. Workshop will focus on critical, analytical & strategic test-taking skills and be facilitated by a panel of regulatory professionals who have earned their RAC.
Coming Soon Coming Soon
Digital Devices: Exploring Real-World Effectiveness of Prescription Digital Therapeutics
Thursday, 08 December 2022 (11:00 - 12:00PM) 0.0 RAC Credits
Virtual Programs Virtual Programs
US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2022)
Wednesday, 25 May 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 NonMembers: $680
This virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Virtual Programs Virtual Programs
3rd Party Servicing: Underreported, Understudied, and Underregulated
Wednesday, 18 May 2022 (1:00 - 2:30PM) 1.5 RAC Credits Pricing: $0
Learn the difference between servicing and re-manufacturing a medical device, the regulatory requirements for each, concerns with unregulated 3rd party servicing activities and potential solutions to the problem.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Tuesday, 07 June 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
Chapter Events Chapter Events
Chicago Chapter Webcast: EU IVDR Update
Monday, 13 June 2022 (11:00 - 1:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
Attend this session to learn the latest updates that can help your organization overcome obstacles for placing devices in the EU under MDR and ensure market continuity after the application date.
Chapter Events Chapter Events
NY/NJ Chapter Webcast- Decision-Making Overview of RWD/RWE Guidances (and RWE Use Successes and Pitfalls)
Monday, 23 May 2022 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
The use of real-world evidence can accelerate drug development and product approvals. However, the acceptable use of real-world evidence for regulatory purposes is a rapidly evolving area where industry.
     
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Books Books
The Medical Device Validation Handbook, Second Edition
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is intended to provide a basic overview of US medical device regulation.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
On-demand On-demand
Understanding and Applying FDA’s 510(k) Modifications Guidance
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
Books Books
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.