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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
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...
ReconRecon
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.
ReconRecon
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...
ReconRecon
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 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...
ReconRecon
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...
ReconRecon
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.
ReconRecon
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.

Event Calendar

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
Risk Management for the Full Product Life Cycle: Design Concept through Post-Market Surveillance
Tuesday, 18 April 2023 (8:00 - 5:00PM) 12.0 RAC Credits Member: $1340 | Nonmmember: $1570
The session demonstrates an approach to sustain and use a Risk Management File throughout the product life. By attending, manufacturers will be better positioned to meet the latest regulatory requirements.
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
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

On-demandOn-demand
Meet the Author: Risk Management Principles for Devices and Pharmaceuticals, Third Edition (On-Demand)
Member: $0 | NonMember: $25
This book aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices.
BooksBooks
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
On-demandOn-demand
Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities (On-Demand)
1.0 RAC Credits
Member: $0 Nonmember: $25
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
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.
On-demandOn-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739 (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
On-demandOn-demand
FDA Forecast: What's Next for the FDA in 2023? (On-Demand)
1.5 RAC Credits
Member: $0 | NonMember: $25
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.
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.
E-booksE-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
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.
     
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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
ReconRecon
Recon: FDA staff say safety issues for Biogen’s ALS drug don’t preclude approval; BioNTech partners with OncoC4 to develop immunotherapy drug
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: FDA’s budget justification, Nurtec ODT recall, and more
ReconRecon
Recon: Pfizer recalls migraine drug over packaging issues; UK lobby group suspends Novo Nordisk after rule violation
On-demandOn-demand
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling (On-Demand)
1.0RAC 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.
Regulatory NewsRegulatory News
FDA seeks 10% boost in Biden’s FY 2024 budget
ReconRecon
Recon: FDA warns of shortages of asthma med albuterol; Bayer plans $1B spend on US pharma R&D in 2023
ReconRecon
Recon: FDA extends review of BioMarin's hemophilia gene therapy; Abbott's blood test for concussions cleared by FDA
This Week at FDAThis Week at FDA
This Week at FDA: Agency starts diagnostics reform rulemaking, top Aduhelm-linked official retiring
On-demandOn-demand
Meet the Author: Risk Management Principles for Devices and Pharmaceuticals, Third Edition (On-Demand)
Member: $0 | NonMember: $25
This book aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices.
ReconRecon
Recon: FDA panel reviews Pfizer, GSK RSV vaccines; Merck scraps Keytruda prostate cancer trial after disappointing Phase III results
ReconRecon
Recon: Pfizer in talks to acquire Seagen; EMA backs approval for 8 new drugs
ReconRecon
Recon: FDA approves Sanofi’s bleeding disorder drug; Sen. Warren calls for scrutiny of Merck’s Keytruda patents