ReconRecon
Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA updates uniform recall procedure
Posted 05 July 2022 By Nick Paul Taylor
Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the ...
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...
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 (12:00 - 1:30PM) 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.

All Results

On-demand On-demand

Meet the Authors: Orphan Drug Development for Rare Diseases

1.0RAC 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)

1.0RAC 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)

1.0RAC 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.
On-demand On-demand

Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)

1.0RAC 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
On-demand On-demand

IVDR 2022: What IVD manufacturers can learn from the MDR rollout

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand

Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices

1.0RAC Credits
Member: $0 NonMember: $25
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
On-demand On-demand

Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand

Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)

6.0RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
Books Books

Global Pediatric Development of Drugs, Biologics, and Medical Devices

Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.