RoundupsRoundups
Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests
Posted 18 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance...
Regulatory NewsRegulatory News
Former commissioners, Woodcock dissect pandemic response, future challenges at FDA
Posted 17 January 2022 By Joanne S. Eglovitch
A panel of former US Food and Drug Administration (FDA) commissioners, moderated by Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’...
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...
ReconRecon
Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm
Posted 17 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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
WHO charts path to convergence on cell and gene therapies
Posted 14 January 2022 By Joanne S. Eglovitch
The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.
Regulatory NewsRegulatory News
Senate committee advances Califf’s nomination as FDA commissioner
Posted 13 January 2022 By Michael Mezher
The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).
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
US Regulatory Essentials, Devices
Tuesday, 22 March 2022 (10:00 - 3:30PM) 12.0 RAC Credits Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
Virtual Programs Virtual Programs
Digital Health: Fundamentals of FDA Regulation
Friday, 11 February 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $160 | Nonmembers: $175
Examine how FDA regulates digital health including SaMD, AI/ML and cybersecurity, and learn about the implications of the new FDA draft guidance on recommended software documentation for premarket submissions.
Virtual Programs Virtual Programs
Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
Wednesday, 23 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
Attend this live broadcast and learn the essentials of e-PIL legislation, a pilot initiative between the pharm industry and regulatory authorities in Belgium and Luxembourg, supported by the European Commission
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.
Virtual Programs Virtual Programs
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
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
Thursday, 10 February 2022 (1:00 - 2:00PM) 1.0 RAC Credits Members $0 | Nonmenbers $0 This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
     
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Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy.
Books Books
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
FDA Law and Regulation [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides an overview of FDA and its associated laws and regulations.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Manufacturing Practice (GMP) [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.
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 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 strategy.
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
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.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Reference Package: Basic
Member: $360 Nonmember: $475
Purchase the Fundamentals of Medical Device Regulations, Third Edition and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.

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Books Books

Promotion of FDA-Regulated Medical Products

Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
On-demand On-demand

US Regulation of Advertising and Promotion of Drugs

6.0RAC Credits
Member: $399.00 Nonmember: $499.00
Examine the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences