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Regulatory NewsRegulatory News
This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?
Posted 03 December 2021 By Michael Mezher, Kari Oakes
Welcome to month two of our weekly digest of regulatory news from the US Food and Drug Administration (FDA) and other corners of the health care product world. This week saw the expansion of Eli Lilly’s emergency use authorization (EUA) ...
TrackersTrackers
COVID-19 vaccine tracker
Posted 03 December 2021 By Jeff Craven
Updated 03 December with new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Bharat Biotech, Shifa Pharmed Industrial Group, and the first authorization of the...
Regulatory NewsRegulatory News
FDA expands eSTAR filing to de novo devices, IVDs
Posted 02 December 2021 By Kari Oakes
US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kic...
Regulatory NewsRegulatory News
FDA announces FY 2022 GDUFA science and research priorities
Posted 02 December 2021 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs.
RoundupsRoundups
Euro Roundup: EMA chief calls for extra staff to handle growing workload
Posted 02 December 2021 By Nick Paul Taylor
The executive director of the European Medicines Agency (EMA) has told politicians her teams need more support to cope with COVID-19 and their soon-to-be-extended mandate.
ReconRecon
Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron
Posted 02 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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EU official says ICH Q6B is outdated and needs revision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...
Virtual Programs Virtual Programs
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications
Thursday, 16 December 2021 (9:00 - 2:00PM) 6.0 RAC Credits Member: $580 Non-Member: $680
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
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
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 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
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence 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
Conflict Resolution and Negotiation: Effective Tools and Techniques (February 2022)
Thursday, 24 February 2022 (8:00 - 9:30AM) 1.5 RAC Credits Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (June 2022)
Friday, 03 June 2022 (1:00 - 2:30PM) 1.5 RAC Credits Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
     
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Books Books
Promotion of FDA-Regulated Medical Products (Paperback)
Member: $125.00 Nonmember: $175.00
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
6.0 RAC 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
On-demand On-demand
US Regulation of Advertising, Promotion and Labeling for Medical Devices
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Through presentations, discussions and case studies, this program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Advertising and Promotional Labeling in the US [4.0 RAC]
4.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is intended to provide a basic overview of US medical device regulation.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
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
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
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.

All Results

Books Books

Promotion of FDA-Regulated Medical Products (Paperback)

Member: $125.00 Nonmember: $175.00
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