This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 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. The biggest news out of FDA this week was the ag...
Regulatory NewsRegulatory News
FDA tells Dutch API producer to clean up its equipment act
Posted 01 July 2022 By Joanne S. Eglovitch
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Admin...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 01 July 2022 By Jeff Craven
Updated 01 July with new information on Paxlovid, Evusheld, molnupiravir, Regkirona and ivermectin.
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition
Posted 01 July 2022 By Ryan Connors
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
Feature ArticlesFeature Articles
Supply chain disruptions: FDA guidance and temporary policies
Posted 30 June 2022 By Tony Subketkaew, JD, Joanna Pearce, JD
The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents...
Feature ArticlesFeature Articles
Proposed updates hint at dietary supplement legislative reform
Posted 30 June 2022 By Krista Hekking, JD, Miriam Guggenheim, JD
The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discus...
Feature ArticlesFeature Articles
Managing regulation of mental health-related claims in the COVID-19 era
Posted 30 June 2022 By Raqiyyah Pippins, JD, Danait Mengist, JD
As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with st...
Feature ArticlesFeature Articles
An update of China’s food safety regulatory framework
Posted 30 June 2022 By Junshi Chen, MD, Chunzhu Wu, MSc
This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formu...
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
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
Root Cause Investigation for CAPA
Tuesday, 26 July 2022 (11:00 - 3:00PM) 12.0 RAC Credits Member: $970| Nonmember: $1150
Investigative tools used to identify technical root causes, systemic root causes, corrective and preventive actions, and control plans to monitor and prevent recurrence.
Chapter Events Chapter Events
Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Tuesday, 26 July 2022 (3:30 - 5:00PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join regulatory professionals for an overview of key learnings obtained on the journey to MDR and IVDR certification.
Virtual Programs Virtual Programs
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
Wednesday, 03 August 2022 (10:00 - 11:00AM) 1.0 RAC Credits Member: $0 | NonMember: $0
In this webcast, experts will review the history of quality systems, look at the changes to quality regulations, and discuss the FDA’s intent to adopt the ISO 13485 standard.
Virtual Programs Virtual Programs
Tackling the CMC Challenges for Cell and Gene Therapy Product Development
Wednesday, 03 August 2022 (12:00 - 2:00PM) 2.0 RAC Credits Price: Member: $195 / Nonmember $230
Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
Virtual Programs Virtual Programs
Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices
Friday, 05 August 2022 (10:00 - 2:00PM) 6.0 RAC Credits Member: $150 NonMember: $175
Key principles and considerations in designing and executing a real-world evidence study for medical-device evaluation will be outlined.
Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
     
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On-demand On-demand
On-demand Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
1.0 RAC Credits
Member: $0 NonMember: $25
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Flashcards
Member: $40.00 Nonmember: $50.00
Study drug terminology at your fingertips in an easy-to-use flashcard format.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Flashcards
Member: $40.00 Nonmember: $50.00
Study devices terminology at your fingertips in an easy-to-use flashcard format.
On-demand On-demand
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
1.0 RAC Credits
Member: $0 NonMember: $25
This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
On-demand On-demand
Meet the Authors: Orphan Drug Development for Rare Diseases
1.0 RAC Credits
Price: $0
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
On-demand On-demand
Best Practices on MDR Transition Under Current Conditions (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
E-books E-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.

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On-demand On-demand

Strategies for Successful PMCF Planning and Execution

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Walks you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements.
On-demand On-demand

Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
On-demand On-demand

Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
On-demand On-demand

How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.
Books Books

The European In Vitro Diagnostic Regulation

Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Books Books

Introduction to the Due Diligence Process, Second Edition

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand

How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
Books Books

Fundamentals of EU Regulatory Affairs, Ninth Edition

Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
On-demand On-demand

Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.
On-demand On-demand

Are You Ready to Begin Planning your IND Submission?

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.