Regulatory Affairs Professionals Society
@RAPSorg
Followers
12K
Following
2K
Media
4K
Statuses
32K
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the healthcare products sector.
Rockville, MD, USA
Joined February 2010
Industry asks for clarification, consistency in FDA’s 510(k) transfer guidance.
raps.org
Medtech industry stakeholders have asked the US Food and Drug Administration (FDA) to make significant changes and clarify its proposed guidance on what regulators expect from companies that acquire...
0
0
0
📝Regulatory due diligence, explained. This expert-backed course can help you prepare for due diligence, so you can make sure your company is ready for any surprises. Learn more about this course:
0
0
0
FDA issues warning letters for CGMP violations, marketing devices for unintended uses.
raps.org
The US Food and Drug Administration (FDA) has cited multiple companies for marketing products for which they were not authorized and for violating current good manufacturing practices (CGMP). @
0
0
1
Our community works all year to make sure #RAPSConvergence serves the entire regulatory affairs community: across sectors, across the globe, and for everyone whose job requires regulatory affairs knowledge. Get your ticket today to save:
0
0
0
Pharma groups suggest changes to FDA’s guidance on replacing color additives.
raps.org
Industry groups representing drugmakers have expressed support for a US Food and Drug Administration@s (FDA) draft guidance that would make it easier to replace color additives in drugs, though they...
0
0
1
The latest round of MDUFA negotiations have started, and @MedTech_Danny was there to capture perspectives from FDA and industry. Read more in Regulatory Focus:
1
0
0
In June 2024, the FDA issued guidance that all Phase 3 and pivotal studies include a diversity action plan as part of their data package. At this live online workshop, experts will dive deep into what this guidance means for regulatory professionals.
1
0
1
In this peer-reviewed article, our authors explore the challenges in planning and executing high-quality Level 4 and general/usability Level 8 PMCF surveys, as outlined in Appendix III of the MDCG 2020-6 guidance document.
0
0
0
FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs.
raps.org
The US Food and Drug Administration (FDA) has cited several manufacturers for failing to conform to current good manufacturing practices (CGMP) and quality system regulation (QSR) requirements. The...
1
0
1
FDA, ASCO propose principles for proper dosing in cancer drug development.
raps.org
The US Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) have laid out several principles for cancer drug developers to ensure more nuanced dosing. The princip...
0
1
4
Agile project management can help regulatory professionals foster relationships, avoid roadblocks, and establish shared expectations among teams. At this webcast with Synterex, learn how the combination of Agile and AI can help you:
0
0
0
Investment in quality management can reduce defects and recalls, FDA says.
raps.org
Companies that invest in quality management initiatives can incur lower costs related to defects, waste, and recalls compared to those that do not make such investments, according to a white paper...
0
0
0
For Tyler Vandivort, the “immediate effect” of his RAC credential came when he applied for a job. But even before that, the RAC was a journey that allowed him to broaden his knowledge of regulatory affairs. Read the full profile:
1
0
1
Manufacturers largely met May DSCSA deadline without major issues, experts say.
raps.org
Supply chain experts said that most manufacturers successfully implemented the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 May deadline without...
0
0
3
In this peer-reviewed article, our authors highlight the similarities and differences in the acceptance of real-world evidence as clinical data for medical devices in the US and the EU:
0
1
2
7-year FDA review finds improved GCP compliance.
raps.org
A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring...
1
0
3
Expedited regulatory pathways exist to fast-track products that can help treat serious diseases and address unmet clinical needs. Learn how your organization can properly utilize them around the globe:
0
0
0
FDA's Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection.
raps.org
The US Food and Drug Administration@s (FDA) Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection (SSDC). @
0
0
0
Submit your proposal for RAPS Euro Convergence 2026, happening in Lisbon, Portugal from 5–8 May. Explore the proposal process and the conference tracks and topics. The deadline to submit is 26 September:
0
0
0