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...
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...
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-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...
Combination Products Summit 2022
Monday, 07 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Since 2015, the Combination Products Summit has united the healthcare products industry to work for a better tomorrow.
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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.
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Regulatory Leadership
Tuesday, 18 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
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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
PharmaLink 2022
Tuesday, 15 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.
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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.
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Biologics CMC: Regulatory Challenges and Trends
Thursday, 27 October 2022 (9:00 - 3:00PM) 12.0 RAC Credits Member: $1,100 | Nonmember: $1,300
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regions
Europe Europe
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Software as a Medical Device
Thursday, 20 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1,080 | Nonmembers: € 1,265
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
     
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On-demand On-demand
Three Real-World Experiences Using a Novel Data Platform
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This program will give you practical insights into new approaches and tools to help manage your business. It will cover 510(k) submission strategy, product code policy assessment, and postmarket safety analysis.
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Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)
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This webcast will cover the development and regulatory process for new therapeutics, proven strategies that help reduce risk of failure, and how to streamline clinical development and increase speed to market.
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COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
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This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
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How Huvepharma Maintains Quality and Innovation in a High Growth Environment
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Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
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Lifecycle Management Through the Rx-to-OTC Switch
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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.
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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.
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Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
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Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
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Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
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Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.