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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...
ReconRecon
Recon: Novo follows Lilly in slashing US insulin prices; FDA staff signal support for Pfizer’s COVID drug in high-risk patients
Posted 14 March 2023 By Michael Mezher
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...
Regulatory NewsRegulatory News
FDA official warns manufacturers of common problems found in aseptic operations
Posted 07 March 2023 By Joanne S. Eglovitch
Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior poli...
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
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
Posted 13 February 2023 By Joanne S. Eglovitch
A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program developed for cell and gene therapies, as the involvement of other “high-income countries” could h...
Regulatory NewsRegulatory News
Clinical data consortium seeks to establish best practices for supplemental controls
Posted 13 February 2023 By Mary Ellen Schneider
The Clinical Research Data Sharing Alliance (CRDSA) is leading a demonstration project that seeks to establish best practices around the use of clinical trial and real-world data (RWD) in building supplemental control arms, as well as se...
ReconRecon
Recon: Pharma loses bid to stop states from importing drugs from Canada; EU approves AstraZeneca’s Forxiga for chronic heart failure
Posted 07 February 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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.
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.
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 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
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
San Francisco Bay Area Chapter Hybrid Event: Top 3 Mistakes to Avoid in your 510(k) Submission to the FDA or Third Party
Wednesday, 12 April 2023 (11:30 - 2:30PM) 2.0 RAC Credits Member: $35 | Non-Member: $45 | Student: $25
The FDA, SaMD & regulatory-strategy experts will offer insight into the top 3 510(k) submission mistakes at this hybrid virtual/in-person session at UCSC Silicon Valley satellite in Santa Clara, CA.
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
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
On-demandOn-demand
Sponsored webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
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.
BooksBooks
Complete WHO Guidance Document Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
BooksBooks
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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.
On-demandOn-demand
Mastering your 510(k) submission process (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
On-demandOn-demand
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Regulation of Biosimilars [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
E-booksE-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
BooksBooks
Essentials of Healthcare Product Labeling
Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
     
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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
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
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.
ReconRecon
Recon: Novo follows Lilly in slashing US insulin prices; FDA staff signal support for Pfizer’s COVID drug in high-risk patients
Regulatory NewsRegulatory News
FDA seeks 10% boost in Biden’s FY 2024 budget
Regulatory NewsRegulatory News
FDA official warns manufacturers of common problems found in aseptic operations
Regulatory NewsRegulatory News
HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
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
Regulatory NewsRegulatory News
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
Regulatory NewsRegulatory News
Clinical data consortium seeks to establish best practices for supplemental controls
ReconRecon
Recon: Pharma loses bid to stop states from importing drugs from Canada; EU approves AstraZeneca’s Forxiga for chronic heart failure
ReconRecon
Recon: FDA links India-made eye drops to serious adverse events and one death; Gilead’s Trodelvy approved for a third US indication