Regulatory NewsRegulatory News
GAO tasks FDA with developing agency-wide workforce plan for medical product staff
Posted 17 January 2022 By Jeff Craven
Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a wo...
Regulatory NewsRegulatory News
This Week at FDA: User fee update, Califf nomination, and more
Posted 14 January 2022 By Michael Mezher
Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transm...
TrackersTrackers
COVID-19 vaccine tracker
Posted 14 January 2022 By Jeff Craven
Updated 14 January to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, CanSino Biologics, Bharat Biotech/Ocugen, Center for Genetic Engin...
Regulatory NewsRegulatory News
Industry seeks delay for reporting manufacturing volume data
Posted 12 January 2022 By Joanne S. Eglovitch
Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security A...
ReconRecon
Recon: Pfizer to cut sales staff as provider meetings move virtual; US buys 600k more doses of GSK-Vir COVID therapy
Posted 11 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents
Posted 07 January 2022 By Michael Mezher
Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s nomination to lead the FDA. Plus, we get word...
Regulatory NewsRegulatory News
FDA approved more first-in-class drugs, gave more accelerated approvals in 2021
Posted 07 January 2022 By Jeff Craven
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020, more drugs were designated as first-in-class and used the...
ReconRecon
Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal
Posted 04 January 2022 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
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: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $970
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
Biologics CMC: Regulatory Challenges and Trends
Thursday, 20 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Receive an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in the US, Europe, and other regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
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 regulated regions.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Monday, 28 February 2022 (9:00 - 5:30PM) 6.0 RAC Credits Member: $495 |Nonmember: $580
An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is for new -intermediate level professionals and those preparing for the RAC Drugs exam
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Books Books
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
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).
Books Books
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $75.00 Nonmember: $105.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of US & EU Biologics [5.0 RAC]
4.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
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.
Books Books
EU Regulatory Acronyms & Definitions, Sixth Edition
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Prep Toolbox with Print Edition of Pharmaceutical and Biologics Fundamentals Book
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.