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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
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...
RoundupsRoundups
Asia-Pacific Roundup: WHO calls for action after Asia-made medicines linked to 300 deaths
Posted 24 January 2023 By Nick Paul Taylor
WHO wants regulators to do more to interrupt the supply of cough syrups contaminated with diethylene glycol and ethylene glycol. The global public health body told regulators and governments to “assign appropriate resources to improve an...
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...
     
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Event Calendar

Virtual ProgramsVirtual Programs
Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
Tuesday, 16 May 2023 (8:00 - 12:00PM) 3.0 RAC Credits Member: $335 | NonMember: $395 This workshop provides an understanding for developing an oligonucleotide CMC regulatory strategy. By attending, regulatory & quality professionals will leverage sound CMC submission drafting approaches.
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.
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 Drug Registration and Reimbursement
Tuesday, 16 May 2023 (1:00 - 2:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.
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
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
BooksBooks
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
BooksBooks
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
BooksBooks
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
BooksBooks
EU Regulatory Acronyms & Definitions, Sixth Edition
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
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.
BooksBooks
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.
BooksBooks
Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
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.
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