Regulatory NewsRegulatory News
Experts: Lack of EU reference labs due to regulatory uncertainties, COVID workload
Posted 15 August 2022 By Ferdous Al-Faruque
The European Commission is having a difficult time getting member states to offer up European Union reference laboratories (EURLs) to review high-risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Medical Devices Regulation ...
Regulatory NewsRegulatory News
UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster
Posted 15 August 2022 By Ferdous Al-Faruque
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s bivalent COVID-19 booster vaccine for adults. The vaccine’s composition is split evenly between components targeting the original 2020 SARS-CoV-2 st...
Regulatory NewsRegulatory News
FDA warns two Massachusetts infusion pump makers owned by same CEO
Posted 15 August 2022 By Ferdous Al-Faruque
Two infusion pump manufacturers were handed similar warning letters for multiple issues, including failing to take adequate corrective actions after receiving product complaints, following up on those complaints and addressing product fa...
ReconRecon
Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns
Posted 15 August 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDAThis Week at FDA
This Week at FDA: Amazon warning letter, ANDA amendments, and more
Posted 12 August 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 take a look at warning letters sen...
Regulatory NewsRegulatory News
Expert: OGD on track to approve more generic drugs in FY2022
Posted 12 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exc...
Feature ArticlesFeature Articles
The value of a ready-to-use therapeutic food guideline for severe malnutrition
Posted 12 August 2022 By Louise T. Göttsche, MSc, MBA
Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical complications. This article focuses on the value of an RUTF guideline. Knowing what is required for childre...
Regulatory NewsRegulatory News
FDA blasts California firm for multiple GLP issues involving nonclinical studies
Posted 11 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the fi...
Virtual Programs Virtual Programs
China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Thursday, 18 August 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us again as the RAPS Twin Cities Chapter hosts another summer Happy Hour!
Virtual Programs Virtual Programs
Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
In-Person In-Person
RAPS Convergence 2022
Sunday, 11 September 2022 (8:00 - 5:00PM) 12.0 RAC Credits Members: $1,940 | Nonmembers: $2,255
Don’t Miss Regulatory’s Premiere Annual Event!
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
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
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
     
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On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
On-demand On-demand
Sponsored Webcast: Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
This webcast will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid pcase reports of manufacturers moving through the transitioning to applying the EU MD
Books Books
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Books Books
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
On-demand On-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
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.

All Results

Books Books

The European Medical Device Regulation (2021 Update)

Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
Books Books

International Combination Products

Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
On-demand On-demand

PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
RAC Exam RAC Exam

RAC Devices Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
RAC Exam RAC Exam

RAC Drugs Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
On-demand On-demand

Plan to Accelerate Your Time to Drug Submissions

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
We'll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies.
On-demand On-demand

Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand

SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies

Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.
Books Books

Software as a Medical Device

Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
On-demand On-demand

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.