Regulatory

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Examining the two areas of weakness cited in FDA draft guidance.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

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.

Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.

EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.