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...
ReconRecon
Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine
Posted 11 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA-led study highlights tradeoffs in drug promotion on social media
Posted 11 August 2022 By Mary Ellen Schneider
Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional...
RoundupsRoundups
Euro Roundup: MDCG posts guidance on notified bodies
Posted 11 August 2022 By Nick Paul Taylor
MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency a...
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
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
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
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
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
1.0 RAC 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.
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.
On-demand On-demand
Meet the Authors, Regulatory Intelligence 101, Third Edition
Member: $0.00 Nonmember: $0.00
The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
Online Course Online Course
An Essential Guide to Horizontal Role Change Thinking
Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online Course Online Course
An Essential Guide to Vertical Career Thinking
Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.

All Results

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.
On-demand On-demand

The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

1.0RAC Credits
Member: $0 Nonmember: $20
This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
On-demand On-demand

PMS Requirements of the EU MDR: Implementation Challenges and Solutions

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
On-demand On-demand

China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
On-demand On-demand

Best Practices for Building An Efficient Literature Review Process

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
Books Books

Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition

Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demand On-demand

Strategic Role of the RA Professional

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities.
On-demand On-demand

EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
On-demand On-demand

AI for Post Market Surveillance Compliance and Regulatory Work According to MDR

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
RAC Prep Bundle RAC Prep Bundle

RAC (Drugs) Reference Package: Basic

Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Device) Practice Test and Flashcards together and save on these indispensable reference tools—our most popular products to help you prepare.