Regulatory

With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.

How will AI best be positioned to help safety professionals best utilize their time and resources?

Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.

Designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, the program provides an opportunity for sponsors to interact with experts from FDA.

Webinar Date/Time: Wednesday, September 13th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Regulatory guidance paves the way to address ethical concerns in pediatric trials, and how additional strategies can be applied in drug evaluation.

Webinar Date/Time: Wednesday, August 16, 2023 at 11am EDT

While underreported, ADR data offers significant value to the drug development value chain to refine the predictive capability and stability, and provide enhanced patient safety.

Insights from Clinical Quality Oversight Forum.

Session at DIA discusses the International Medical Device Regulators Forum (IMDRF), its importance and how harmonization could be improved.

CDER and CBER leaders update initiatives in the rare disease space within the past year.

Webinar Date/Time: Thu, Jul 20, 2023 11:00am EDT | 4pm BST | 5pm CEST

First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

Harmonization could turn the continent into an established site for clinical research and laboratories.

This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.

EU’s sweeping push for major pharma reforms to impact the daily practice of clinical trials community.

Dissecting the EMA’s new annual report on milestones reached in clinical research and public health.

Examining the two areas of weakness cited in FDA draft guidance.

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.

Key considerations for successful implementation in decentralized clinical trials.

Patient insights are expected to become increasingly instrumental in optimizing medicine development and regulatory decision-making.

Estelle Jobson, EUPATI alumna, patient expert and health communications professional discusses changes to the EU's requirements for clinical trial lay summaries.

Utilizing a broad network of provider sites is key in overcoming failure and enabling access to high quality data.

Recommendations apply to where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

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.

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.

Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.