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Regulatory NewsRegulatory News
FDA takes steps to relax blood donor requirements
Posted 23 May 2022 By Ferdous Al-Faruque
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to...
Regulatory NewsRegulatory News
MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR
Posted 23 May 2022 By Joanne S. Eglovitch
The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Devic...
Feature ArticlesFeature Articles
FDA guidances for medical device regulation after enforcement discretion and EUA expiration
Posted 23 May 2022 By Ashley Clark, MS, RAC
This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires.  Keyw...
Regulatory NewsRegulatory News
Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
Posted 23 May 2022 By Jeff Craven
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not pre...
ReconRecon
Recon: Pfizer, BioNTech seek vaccine EUA for children under 5; EU authorizes AstraZeneca COVID booster
Posted 23 May 2022 By Michael Mezher
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 advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot
Posted 20 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. It was a busy week for FDA on the Hill again, wit...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 20 May 2022 By Jeff Craven
Updated 20 May with new information on Paxlovid, Veklury (remdesivir), Xevudy (sotrovimab), Olumiant/Baricinix (baricitinib), and Gleevec/Glivec (imatinib).
Regulatory NewsRegulatory News
FDA asks manufacturers to develop risk management plans to avert shortages
Posted 20 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drug and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also reco...
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.
Virtual Programs Virtual Programs
Ensure Your MDR Program is State of the Art
Tuesday, 24 May 2022 (12:00 - 1:30PM) 1.5 RAC Credits Price: $0
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
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
Conflict Resolution and Negotiation: Effective Tools and Techniques (June 2022)
Friday, 03 June 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
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
NY/NJ Chapter Webcast: Panel Discussion on Leadership Journeys: Navigating Career Paths in Regulatory Affairs
Tuesday, 07 June 2022 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join us for a panel discussion by six Women Leaders who have navigated and overcome barriers to chart paths for themselves and others in RA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Wednesday, 08 June 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us as the RAPS Twin Cities Chapter kicks off our first in-person event for 2022!
Virtual Programs Virtual Programs
Sponsored Webcast: Postmarket Clinical Follow-up Under MDR
Thursday, 09 June 2022 (11:00 - 12:00PM) 1.0 RAC Credits Price: $0
This free webcast will provide an overview of how to plan and execute the PMCF requirements under MDR, taking into consideration key factors such as novelty, longevity on the market, and risk classification.
     
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On-demand On-demand
Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)
Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
On-demand On-demand
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
On-demand On-demand
Ensure Your MDR Program is State of the Art (On-Demand)
1.5 RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
On-demand On-demand
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
On-demand On-demand
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
1.0 RAC Credits
Member: $0 NonMember: $25
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
On-demand On-demand
Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective
1.0 RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand
Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance
1.0 RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.

All Results

On-demand On-demand

Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)

Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
On-demand On-demand

Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
On-demand On-demand

Ensure Your MDR Program is State of the Art (On-Demand)

1.5RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
On-demand On-demand

Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
This webinar will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
On-demand On-demand

Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

1.0RAC Credits
Member: $0 NonMember: $25
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
On-demand On-demand

Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective

1.0RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand

Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand

Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance

1.0RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.
On-demand On-demand

Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)

1.5RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
On-demand On-demand

2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.