Regulatory

Examining the two areas of weakness cited in FDA draft guidance.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

Panel finds potential drug rule difficult to manage.

The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.

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.

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

Webinar Date/Time: Wednesday, March 29th, 2023 at 11am | 8am PDT | 4pm BST | 5pm CEST

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Pandemic and supply shortage among factors in slow transition to new rules.

Probe targets agency’s role in advising on drug testing and submissions.

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

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.