Regulatory Insights
-
Considerations For Plain Language Summaries
4/22/2024
Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.
-
When Quickbooks Leaves Your Life Sciences Venture Struggling
4/18/2024
Is QuickBooks keeping pace with your life sciences venture? Learn the signs it's time to move beyond and adopt tailored solutions for growth, compliance, collaboration, security, and automation.
-
Clinical Research As A Delicate Ecosystem
4/18/2024
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
-
Diversity And Inclusion In Oncology Clinical Trials
4/17/2024
Despite challenges, learn how sponsors can implement diversity plans to enroll and retain clinically relevant participants, including minorities, older patients, and those with disabilities.
-
Success Planning For An Original NDA/BLA Submission
4/15/2024
Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).
-
2024 MedTech Regulatory Updates: 4 Areas Of Interest
4/15/2024
In 2024, McKinsey's projections foresee a promising year for the MedTech industry, driven by innovation but shadowed by regulatory uncertainty.
-
FDA’s Updated Draft Guidance On Reporting Of Diversity Data
4/15/2024
To ensure the safety and effectiveness of medical products for different populations, learn how the FDA is standardizing data collection and reporting for all new clinical trials and studies.
-
EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.
-
Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
-
Future Clinical Trials: Embracing Standardization And Automation
4/10/2024
Through standardized protocols and automation integration, uncover how the industry is poised to unlock new levels of productivity and innovation, advancing the development of safe and effective treatments for patients worldwide.