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Regulatory NewsRegulatory News
New reports address generics pricing, innovation in the EU
Posted 01 December 2021 By Kari Oakes
A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation ...
Regulatory NewsRegulatory News
EU official says ICH Q6B is outdated and needs revision
Posted 01 December 2021 By Joanne S. Eglovitch
The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concep...
RoundupsRoundups
FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor
Posted 01 December 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate
Posted 01 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Public-private initiative expands support for NGS tests
Posted 30 November 2021 By Kari Oakes
A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS data...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
RAPS releases updated Regulatory Competency Framework
Posted 30 November 2021 By Zachary Brousseau
RAPS today announced the release of its updated Regulatory Competency Framework, describing the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to r...
Regulatory NewsRegulatory News
Experts: Penumbra recall highlights ‘device creep,’ makes case for regulatory reform
Posted 30 November 2021 By Mary Ellen Schneider
The recent class I recall of a Penumbra cardiac device used in mechanical thrombectomy procedures provides a case study for the shortcomings of the current 510(k) medical device clearance process and the need for more robust device adver...
RoundupsRoundups
Asia-Pacific Roundup: TGA defies medtech industry by retaining definition of central circulatory system
Posted 30 November 2021 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is keeping its definition of the central circulatory system (CCS) despite universal support for change among medtech respondents to a consultation.
Virtual Programs Virtual Programs
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements
Wednesday, 01 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
Chapter Events Chapter Events
New York/New Jersey Chapter Webcast: PDUFA VII
Thursday, 02 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25
Learn about the soon reauthorized Prescription Drug User Fee Act (PDUFA VII) changes and what it means for the pharmaceutical and biopharmaceutical industries.
Chapter Events Chapter Events
Atlanta Chapter: Annual Breakfast with the Atlanta Southeast FDA District Office
Friday, 03 December 2021 (9:00 - 11:00AM) 2.0 RAC Credits Member: $10 Nonmember: $25
Join us for a virtual breakfast to engage with the Atlanta Southeast FDA District Office representatives and get your hard-pressed questions answered.
Virtual Programs Virtual Programs
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
Monday, 06 December 2021 (10:00 - 11:00AM) 0.0 RAC Credits Member: $0 NonMember: $0
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.
Virtual Programs Virtual Programs
Rollout IVDR 2022: What can IVD manufacturers learn from the MDR rollout when establishing compliance for their IVD devices by May 2022?
Tuesday, 07 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Fee: $0
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 when determining regulatory strategy
Virtual Programs Virtual Programs
Sponsored Webcast: The Evolving Regulatory Real-World Evidence Landscape: Understanding FDA's 2021 RWE Guidance
Thursday, 09 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Member: $0 NonMember: $0
Join a discussion on FDA’s RWE guidance landscape, including how new draft guidance fits into the current ecosystem and implications for biopharma organizations as they develop evidence generation strategies.
Virtual Programs Virtual Programs
FDA Forecast: What’s Next for the FDA in 2022?
Thursday, 09 December 2021 (12:00 - 1:30PM) 1.5 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.
Chapter Events Chapter Events
Wisconsin Chapter Webcast: Regulatory Landscape for Artificial Intelligence (AI)
Friday, 10 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25
Learn the shortcomings of the current approaches at a national and international level to support standards and regulatory development needed to advance the use of Artificial Intelligence.
     
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On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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.
E-books E-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
On-demand On-demand
Artificial Intelligence: A Regulatory Perspective
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Combination Products: Regulatory Approach and cGMP Requirements
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand
Understanding Key Components of a Clinical Evaluation
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This broadcast will explain the key changes of clinical evaluation, review phases for clinical evaluation, explain expectations for systematic literature review, and identify types of clinical support data.
On-demand On-demand
The Aftermath of MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.

All Results

On-demand On-demand

Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities

1.0RAC Credits
Member: $0 Nonmember: $20
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
On-demand On-demand

Navigating Today’s Regulatory Trends to Successfully Manage eCTD Submissions

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment.
On-demand On-demand

Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.
On-demand On-demand

Stay on Track and Get Some Sleep: Marketing Application Best Practices

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
Books Books

Global Medical Device Regulatory Strategy, Second Edition (Hardcover)

Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
On-demand On-demand

Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
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.