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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...
Generating evidence for racial and ethnic minorities during development of oncologic therapeutics
Discussions regarding diversity, equity, and inclusion in healthcare and clinical research have been ongoing for decades. However, the COVID-19 global pandemic brought about a new focus on this issue. As the pharmaceutical industry began...
Enhancing collaboration, access, and research using patient-generated data
Posted 22 March 2023 By Laura E. Gressler, MS, PhD • Art Sedrakyan, MD, PhD
Patient-provided information (PPI) and patient-generated health data (PGHD) are critical sources of real-world data and evidence. Collecting this data empowers patients to become partners in informed decision making by all healthcare sta...
Regulatory NewsRegulatory News
FDA issues guidance on submission of pharmacogenomic data
Posted 21 March 2023 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applicat...
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
ICH adopts S12 guideline for gene therapies
Posted 20 March 2023 By Michael Mezher
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached Step 4 of the ICH process, meaning it’s ready for regul...
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...
RoundupsRoundups
Euro Roundup: Commission delays notified body reassessments to free up capacity for MDR, IVDR
Posted 16 March 2023 By Nick Paul Taylor
The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.
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
EMA-FDA parallel scientific advice program has ‘limited’ uptake
Posted 14 March 2023 By Mary Ellen Schneider
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) shows that the agencies received a total of 37 applications from sp...
RoundupsRoundups
Latin America Roundup: Mexico, Colombia and Cuba press for Pan-American regulatory body
Posted 13 March 2023 By Jennie Smith
The push toward a regional super-agency is being spearheaded by Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS), with strong support from Colombia’s National Institute of Food and Drug Monitoring (INVIMA), and ...

Event Calendar

Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
NY/NJ Chapter Webcast: Regulatory Opportunities and challenges with mRNA Technology- Lessons Learned from the COVID-19 Pandemic
Monday, 12 June 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 | NonMemeber $25
This webcast will describe the current regulatory framework applicable to mRNA products and explain the regulatory challenges and opportunities that have been enabled with mRNA technology.
In-PersonIn-Person
Biologics CMC: Phase Appropriate Product Development (April 2023)
Thursday, 27 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1340 | NonMember: $1570
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
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.
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

On-demandOn-demand
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
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!
E-booksE-books
Postapproval Changes for Drugs: A Practical Guide (e-book)
Member: $160.00 Nonmember: $225.00
This guide covers postapproval changes from marketing authorization transfers, administrative changes, late phase renewals through to additional indications.
On-demandOn-demand
CMC - An Integral Component of Cell and Gene Therapy Development (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
BooksBooks
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demandOn-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
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.
On-demandOn-demand
A Risk-Based Approach to Validation for Life Sciences Companies (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.
BooksBooks
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $147.50 Nonmembers: $197.50
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
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.
BooksBooks
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $147.50 Nonmembers: $197.50
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
BooksBooks
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
     
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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