Regulatory NewsRegulatory News
Industry groups challenge FDA’s LASIK guidance, call for withdrawal
Posted 29 November 2022 By Ferdous Al-Faruque
Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on laser-assisted in situ keratomileusis (LASIK) patient labeling, arguing that the agency’s recommendations are...
Regulatory NewsRegulatory News
FDA relaxes EUA advertising limitation for some COVID drugs
Posted 16 November 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs). The agency said that “truthful and non-misleading” advertising and promo...
This Week at FDAThis Week at FDA
This Week at FDA: Guidance tsunami continues, questions about FDA’s accelerated approval pathway
Posted 21 October 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The US Food and Drug Administration (FDA) has co...
This Week at FDAThis Week at FDA
This Week at FDA: It’s raining user-fee guidances, Hallelujah!
Posted 07 October 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The big news this week is the firehose of guidan...
RoundupsRoundups
Asia-Pacific Roundup: Australia seeks feedback on making references to TGA in product advertising
Posted 27 September 2022 By Nick Paul Taylor
Australia is holding a consultation on whether to allow advertisers to make references to the Therapeutic Goods Administration (TGA) in their promotional materials. TGA is seeking feedback on a wide range of options, from maintaining the...
Regulatory NewsRegulatory News
FDA-led study highlights tradeoffs in drug promotion on social media
Posted 11 August 2022 By Mary Ellen Schneider
Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional...
Regulatory NewsRegulatory News
This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report
Posted 29 July 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, the US Food and Drug Administration (F...
Regulatory NewsRegulatory News
FDA offers new guidance on therapeutic equivalence evaluations
Posted 20 July 2022 By Michael Mezher
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, which are listed in the agency’s Ora...
RoundupsRoundups
Euro Roundup: COVID vaccines drive 93% jump in EudraVigilance reports
Posted 21 April 2022 By Nick Paul Taylor
The number of authorized product suspected adverse reactions sent to EudraVigilance jumped 93% last year because of a surge in reports related to COVID-19 vaccines. Almost half of the record 3.5 million individual case safety reports (IC...
Regulatory NewsRegulatory News
Stakeholders ask for more time to transition EUA devices, diagnostics
Posted 25 March 2022 By Ferdous Al-Faruque
Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the age...
Regulatory NewsRegulatory News
EMA releases draft guidelines on GVP for pregnancy prevention programs
Posted 15 March 2022 By Jeff Craven
The European Medicines Agency (EMA) has released a guideline on good pharmacovigilance practices (GVP) for pregnancy prevention programs in the European Union for public consultation.
Regulatory NewsRegulatory News
OPDP’s first warning letter of 2022 targets CytoDyn for COVID claims
Posted 22 February 2022 By Michael Mezher
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a rare warning letter – its first for 2022 – to CytoDyn after the company posted a video interview last September of its then-CEO Nader Pourhas...
     
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In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM) 0.0 RAC Credits For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
New York / New Jersey & DC/ Baltimore Chapters: An FDA Review and What's Next for Regulatory Professionals in 2023
Tuesday, 28 February 2023 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 | Nonmembers: $25
This webinar provides an overview of the significant FDA action in 2022, and helps regulatory professionals identify important areas of focus for 2023.
Virtual ProgramsVirtual Programs
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM) 1.5 RAC Credits Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM) 1.0 RAC Credits Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.

Books   |   Learning

On-demandOn-demand
Meet the Author, International Combination Products, First Edition (On-Demand)
1.0 RAC Credits
Price: $0 Hear from the expert who wrote the book!
Online CourseOnline Course
Pharmaceutical Labeling: Introduction to an Essential Function
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
On-demandOn-demand
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
On-demandOn-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
BooksBooks
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
On-demandOn-demand
Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical 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 CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Medical Devices: Advertising and Promotion in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Introductory Medical Writing [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical 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 CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Pharmacovigilance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives.
     
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RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM)
For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
New York / New Jersey & DC/ Baltimore Chapters: An FDA Review and What's Next for Regulatory Professionals in 2023
Tuesday, 28 February 2023 (12:00 - 1:00PM)
1.0RAC Credits
Member: $0 | Nonmembers: $25
This webinar provides an overview of the significant FDA action in 2022, and helps regulatory professionals identify important areas of focus for 2023.
Virtual ProgramsVirtual Programs
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM)
1.5RAC Credits
Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
Online CourseOnline Course
Pharmaceutical Labeling: Introduction to an Essential Function
2.0RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.