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.
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...
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...
Regulatory NewsRegulatory News
Consent decree shuts down Utah herbal firm
Posted 20 October 2021 By Kari Oakes
The filing came after FDA issued a 2017 warning letter to the supplement manufacturer, which then continued marketing and selling its products with claims that made them unapproved and misbranded drugs, rather than the dietary suppleme...
ReconRecon
Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations
Posted 20 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices (November 2021)
Thursday, 18 November 2021 (10:00 - 4:00PM) 12.0 RAC Credits This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs. It will cover laws, regulations, FDA guidance, strategies for FDA submissions, advertising and labeling, post-market compliance, and more.
Virtual Programs Virtual Programs
Expedited Pathways (US/Global) – Medical Device
Monday, 15 November 2021 (8:30 - 4:15PM) 12.0 RAC Credits Led by a veteran regulatory manager, this workshop will focus on expedited pathways by FDA, EU, China NMPA and other regulatory agencies from major global markets as to map out a pathway to bring products to market as fast as possible.
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
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
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900 Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Rollercoaster Ride Ahead: Time Is Short for EU IVDR Transition
Wednesday, 10 November 2021 (10:00 - 3:30PM) 6.0 RAC Credits At this stage, manufacturers must be finalizing their transition plan for applying these new requirements to keep their devices in the EU market. Join this two-day workshop for help in developing a clearer path to your transition plan.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Wednesday, 17 November 2021 (9:00 - 5:30PM) 6.0 RAC Credits An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is tailored for new to intermediate level professionals and those preparing for the RAC Drugs examination.
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.
     
  •  
  • 1
  •  
  • 2
  •  
  •  
On-demand On-demand
Meet the Author, International Combination Products, First Edition
Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product
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
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
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.

All Results

On-demand On-demand

Meet the Author, International Combination Products, First Edition

Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
Books Books

International Combination Products (Paperback)

Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.