Regulatory NewsRegulatory News
This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports
Posted 24 March 2023 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. It’s been a busy week for the agency as Xavier B...
Regulatory NewsRegulatory News
FDA outlines plan for digital health technologies for clinical trials
Posted 24 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidanc...
Regulatory NewsRegulatory News
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs
Posted 23 March 2023 By Ferdous Al-Faruque
The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to deve...
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Recon: Moderna sets COVID vax price at $130/shot; Bancel defends decision at Senate hearing
Posted 23 March 2023 By Denise Fulton
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: FDA weighs another round of COVID boosters for high-risk individuals; Thermo Fisher, Celltrion in running to buy Baxter’s biopharma business
Posted 21 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA’s top cybersecurity officials discuss heightened threats, technology modernization
Posted 20 March 2023 By Ferdous Al-Faruque
In a nondescript building in North Bethesda, Maryland, the US Food and Drug Administration (FDA) houses a cybersecurity control center responsible for protecting its digital assets. Since the beginning of the COVID-19 pandemic, the agenc...
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Recon: FDA staff say safety issues for Biogen’s ALS drug don’t preclude approval; BioNTech partners with OncoC4 to develop immunotherapy drug
Posted 20 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: FDA’s budget justification, Nurtec ODT recall, and more
Posted 17 March 2023 By Michael MezherFerdous 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, FDA released more details on its FY20...
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Recon: Pfizer recalls migraine drug over packaging issues; UK lobby group suspends Novo Nordisk after rule violation
Posted 16 March 2023 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA seeks 10% boost in Biden’s FY 2024 budget
Posted 09 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration’s (FDA) is seeking to increase its budget authority by 10% in fiscal year 2024 as part of the Biden administration’s $6.9 trillion budget request. While the budget request also includes multiple legisl...
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Recon: FDA warns of shortages of asthma med albuterol; Bayer plans $1B spend on US pharma R&D in 2023
Posted 09 March 2023 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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Recon: FDA extends review of BioMarin's hemophilia gene therapy; Abbott's blood test for concussions cleared by FDA
Posted 07 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Virtual ProgramsVirtual Programs
RAPS Webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM) 1.0 RAC Credits Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.
Virtual ProgramsVirtual Programs
Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals
Wednesday, 26 April 2023 (11:00 - 12:00PM) 1.0 RAC Credits Price: Free
This program is meant to provide attendees a general foundation on the AI topic to help better understand how this may related to their profession now and in the future.
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).
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Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
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China NMPA Regulations on IVD and Companion Diagnostics (April 2023)
Tuesday, 11 April 2023 (8:30 - 12:30PM) 12.0 RAC Credits Member: $970 NonMember: $1150
This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products and companion diagnostics (CDx).
In-PersonIn-Person
Root Cause Investigation for CAPA (June 2023)
Wednesday, 21 June 2023 (9:00 - 5:00PM) 12.0 RAC Credits Member: $1340 | Nonmember: $1570
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges, particularly in highly regulated industries.

Books   |   Learning

BooksBooks
International Regulatory Acronyms & Definitions, Third Edition
Member: $10.00 Nonmember: $15.00
International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
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Canadian Regulatory Acronyms & Definitions, Fifth Edition
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
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Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
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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.
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Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
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Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
In this webcast, 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.
     
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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 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 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
Root Cause Investigation for CAPA (June 2023)
Wednesday, 21 June 2023 (9:00 - 5:00PM)
12.0RAC Credits
Member: $1340 | Nonmember: $1570
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges, particularly in highly regulated industries.
Virtual ProgramsVirtual Programs
RAPS Webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.
Virtual ProgramsVirtual Programs
Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals
Wednesday, 26 April 2023 (11:00 - 12:00PM)
1.0RAC Credits
Price: Free
This program is meant to provide attendees a general foundation on the AI topic to help better understand how this may related to their profession now and in the future.
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
China NMPA Regulations on IVD and Companion Diagnostics (April 2023)
Tuesday, 11 April 2023 (8:30 - 12:30PM)
12.0RAC Credits
Member: $970 NonMember: $1150
This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products and companion diagnostics (CDx).
Virtual ProgramsVirtual Programs
Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.