Regulatory NewsRegulatory News
FDA withdraws more than 200 ANDAs over unsubmitted annual reports
Posted 21 October 2021 By Michael Mezher
Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday s...
Regulatory NewsRegulatory News
Continuous manufacturing bill clears House
Posted 21 October 2021 By Joanne S. Eglovitch
The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country.
Regulatory NewsRegulatory News
HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures
Posted 21 October 2021 By Mary Ellen Schneider
US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump Administration, calling them a “burden” and “inconsistent with the policies and goals of the current Admin...
RoundupsRoundups
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions
Posted 21 October 2021 By Nick Paul Taylor
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking fe...
ReconRecon
Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug
Posted 21 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires
Posted 21 October 2021 By Joanne S. Eglovitch
Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administratio...
Regulatory NewsRegulatory News
FDA okays Moderna, J&J, 'mix and match' boosters
Posted 20 October 2021 By Kari Oakes
The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizi...
Chapter Events Chapter Events
Utah Chapter Webcast: MDD to EU MDR transition – Will MyLegacy Product Portfolio Get Certified Under the EU MDR?
Thursday, 21 October 2021 (9:00 - 10:30AM) 1.5 RAC Credits Member: $10 Nonmember: $25 Don’t miss this unique opportunity to explore the transition from MDD to EU MDR with two subject matter experts.
Chapter Events Chapter Events
Ontario Chapter Webcast: When FDA does not agree: An Analysis of FDA disagreements with the sponsor
Friday, 22 October 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25 What should a sponsor do if the FDA disagrees? Join the Ontario Chapter to examine and learn what tactics to do when such occasions arise.
Virtual Programs Virtual Programs
Sponsored Webcast: Three Real-World Experiences Using a Novel Data Platform
Tuesday, 26 October 2021 (12:00 - 1:30PM) 1.0 RAC Credits Member: $0 NonMember $0 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.
Chapter Events Chapter Events
Chicago Chapter Webcast: Getting from Data to Sufficient Clinical Evidence for EU-MDR
Wednesday, 27 October 2021 (11:00 - 1:00PM) 2.0 RAC Credits Member: $10 Nonmember: $25 Learn how the clear definition of safety and performance outcomes will serve as the foundation to analyze the data and support the determination if there is sufficient clinical evidence.
Virtual Programs Virtual Programs
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
Thursday, 28 October 2021 (10:00 - 11:15AM) 1.5 RAC Credits 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, clinical evaluation principles and data appraisals.
Virtual Programs Virtual Programs
Biologics CMC: Future Trends, Current Trends and Regulatory Challenges
Tuesday, 02 November 2021 (9:00 - 4:00PM) 12.0 RAC Credits This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other regulated regions.
Virtual Programs Virtual Programs
Artificial Intelligence: A Regulatory Perspective
Wednesday, 03 November 2021 (10:00 - 11:00AM) 1.0 RAC Credits This webcast will provide an overview of terminology and concepts in Artificial Intelligence, review the regulatory requirements in the EU market, cover real-world examples of commercial solutions and explore emerging future challenges of AI.
Virtual Programs Virtual Programs
Sponsored Webcast: How Huvepharma Maintains Quality and Innovation in a High Growth Environment
Thursday, 04 November 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0 Experts from a leading global provider of animal health and nutrition products, Huvepharma, will explain how a flexible Quality Management System (QMS) has a played a crucial role in their business success.
     
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On-demand On-demand
Europe Europe
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
Europe Europe
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
Europe Europe
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.
On-demand On-demand
Europe Europe
Three Real-World Experiences Using a Novel Data Platform
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
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
Europe Europe
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 clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Europe Europe
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.
Europe Europe
Books Books
Lifecycle Management Through the Rx-to-OTC Switch (Paperback)
Member: $125.00 Nonmember: $175.00
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.

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On-demand On-demand
Europe Europe

Artificial Intelligence: A Regulatory Perspective

1.0RAC 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
Europe Europe

Understanding Key Components of a Clinical Evaluation

1.0RAC 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
Europe Europe

The Aftermath of MDR

1.0RAC 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
Europe Europe

Three Real-World Experiences Using a Novel Data Platform

1.0RAC 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

How Huvepharma Maintains Quality and Innovation in a High Growth Environment

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
Europe Europe

China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast

1.0RAC 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
Europe Europe

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

1.0RAC 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.
Europe Europe
Books Books

Lifecycle Management Through the Rx-to-OTC Switch (Paperback)

Member: $125.00 Nonmember: $175.00
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 Medical Device Regulations, Fourth Edition (Hardcover)

Member: $295.00 Nonmember: $395.00
Bundle includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, international).
Books Books

Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition (Hardcover)

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).