February 6th 2024
GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
November 2nd 2023
New laws leave consumers unprotected against third parties accessing their genetic data.
October 13th 2023
Agency will be reorganizing field force and compliance functions.
September 27th 2023
Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.
EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.
EU Perspectives: Guidance for Using Patient Experience Data in Real-World Studies
Patient insights are expected to become increasingly instrumental in optimizing medicine development and regulatory decision-making.
Pharma 2023: New Rules for Clinical Lay Summaries in EU
Estelle Jobson, EUPATI alumna, patient expert and health communications professional discusses changes to the EU's requirements for clinical trial lay summaries.
Overcoming the Pitfalls of Using Real-World Evidence in Regulatory Submissions
Utilizing a broad network of provider sites is key in overcoming failure and enabling access to high quality data.
FDA Issues New Draft Guidance on DCTs
Recommendations apply to where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
FDA Eyes New Strategies to Spur Gene Therapy Development
Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.
The End of the Beginning for Digital Endpoints?
New European report digs deeper into the potential of digital health-driven outcome measures—perhaps a hopeful step in the journey from theory to practice.
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers
January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
Court Ruling Leaves FDA Authority in Limbo
The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.
Agenda Aims to Recharge UK-Based Clinical Trial Innovation
Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.
Raising its Profile: The Changing Practice of Pharmacovigilance
PV is on the road to becoming a leader, not a follower, in leveraging drug lifecycle information for clinical trials and to inform clinical care.
FDA Regulatory Authority Under Attack
Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.
Europe Enhances Regulatory Support for Tackling Unmet Medical Need
EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.
FDA, Industry Prepare for End to COVID Health Emergency
Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.
DIA Europe 2023: Digital Transformation in the EU Regulatory Space
DIA Europe 2023: Combination Drug-Device Regulation in Malaysia, Australia and South Korea
Panel finds potential drug rule difficult to manage.
Filling the Gaps in European Clinical Trial Reporting
The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.
EFPIA: Trials Hampered by New Rules on In Vitro Diagnostics
Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.
How Generative AI and Chat GPT Together with Intelligent Document Review Can Help Pharma Accelerate Filings
Webinar Date/Time: Session 1: Tuesday, April 18th, 2023 at 8am EDT | 1pm BST | 2pm CEST Session 2: Tuesday, April 18th, 2023 at 2pm EDT | 11am PDT | 7pm BST
Virtual Sites—Are they the Future of RWE?
Webinar Date/Time: Wednesday, March 29th, 2023 at 11am | 8am PDT | 4pm BST | 5pm CEST
Kudos and Hurdles in Tackling Rare Diseases
The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.
Hints on Looming Changes to European Clinical Trial Rules
Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.
UK Gov’t Offers a ‘Review’ Amid Clamor Over Declining Clinical Research
The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.
Analysis: IRBs Need More Monitoring
Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.
European Commission Adopts Proposal to Delay MDR Deadlines
Pandemic and supply shortage among factors in slow transition to new rules.
FDA Interactions With Industry Under the Microscope
Probe targets agency’s role in advising on drug testing and submissions.
EU Seeking Wider Views in Its Push to Promote Clinical Trials
EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.
Clinical Trial Diversity Continues to Face Challenges
With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.
FDA Food Center Reorganization Puts Field Inspections in Limbo
Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.
OpenFDA Drug Interaction Visualizer Launched
Artem Andrianov, CEO of Cyntegrity, discusses the launch of his company's new tool; the Drug Interaction Visualizer.
Eight Years Later, Europe’s ‘New’ Clinical Trial Rules Finally Come into Force
Formal compliance with EU’s Clinical Trials Regulation takes effect, designed to speed up the application and approval of studies.