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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
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...
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...
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 Mezher • 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, FDA released more details on its FY20...
Regulatory NewsRegulatory News
Human factors guidance: Stakeholders ask for clarity, less burdensome approach
Posted 13 March 2023 By Ferdous Al-Faruque
Industry groups have challenged several aspects of the US Food and Drug Administration’s (FDA) recent draft guidance on the human factors (HF) information in medical device marketing submissions. While the agency describes its approach a...
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...
Regulatory NewsRegulatory News
HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
Posted 21 February 2023 By Ferdous Al-Faruque
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to addr...
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: Califf calls for adcomm reform, first OTC naloxone may be on horizon
Posted 17 February 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. This week, FDA Commissioner Robert Califf called...
Regulatory NewsRegulatory News
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
Posted 03 February 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. This week, the agency announced the launch of a ...
Regulatory NewsRegulatory News
FDA proposes streamlining inspections office along with new human foods center
Posted 31 January 2023 By Ferdous Al-Faruque
The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies...
Regulatory NewsRegulatory News
OIG report highlights shortcomings in FDA’s IT acquisition procedures
Posted 18 January 2023 By Ferdous Al-Faruque
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency de...
Regulatory NewsRegulatory News
FDA looking externally and internally to develop future IT leaders
Posted 16 January 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more effi...

Event Calendar

Virtual ProgramsVirtual Programs
Sponsored Webcast: Oops, I Messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes
Wednesday, 19 April 2023 (11:00 - 12:00PM) 1.0 RAC Credits Free
This webcast will provide understanding of common mistakes, errors, and omissions in regulatory submissions with insight to avoid or solve them.
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).
Virtual ProgramsVirtual Programs
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.
Virtual ProgramsVirtual Programs
Practical Application of ISO14971: 2019 Risk Management for Medical Devices
Thursday, 04 May 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This webinar will provide practical advice on building or remediating a medical device risk management system that complies with ISO14971:2019, and supports compliance with other medical device regulations
Chapter EventsChapter Events
DC/ Baltimore Chapter Webcast: Conducting a Biocompatibility Risk Assessment for a Submission
Tuesday, 09 May 2023 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $25
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing various regulatory submissions.
Virtual ProgramsVirtual Programs
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
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.
BooksBooks
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.
On-demandOn-demand
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.
Chapter EventsChapter Events
DC/ Baltimore Chapter Webcast: Conducting a Biocompatibility Risk Assessment for a Submission
Tuesday, 09 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Member: $0 | Nonmember: $25
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing various regulatory submissions.
Virtual ProgramsVirtual Programs
Practical Application of ISO14971: 2019 Risk Management for Medical Devices
Thursday, 04 May 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This webinar will provide practical advice on building or remediating a medical device risk management system that complies with ISO14971:2019, and supports compliance with other medical device regulations
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
Sponsored Webcast: Oops, I Messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes
Wednesday, 19 April 2023 (11:00 - 12:00PM)
1.0RAC Credits
Free
This webcast will provide understanding of common mistakes, errors, and omissions in regulatory submissions with insight to avoid or solve them.
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.
Regulatory NewsRegulatory News
This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports
Regulatory NewsRegulatory News
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs
Regulatory NewsRegulatory News
FDA’s top cybersecurity officials discuss heightened threats, technology modernization
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: FDA’s budget justification, Nurtec ODT recall, and more