Regulatory

Compliance with diverse clinical trial payment and data standards requires specialized skills.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses the goals of the EU clinical trial regulation.

Preventing delays and accelerating the progression of these critical therapies.

A look at the insights and implications surrounding the agency's recommendations on using RWE from electronic health records and medical claims data.

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators.

According to a recent Phase II clinical trial conducted by Johns Hopkins Kimmel Cancer Center, all enrolled patients experienced a prostate-specific antigen reduction of 50% or more when treated with Olaparib.

In part 2 of this conversation, Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

Webinar Date/Time: Wednesday, September 11th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

In part 4 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA highlights how the regulators are addressing new technology with updated guidances.

Webinar Date/Time: Tuesday, August 27, 2024 at 11:00 AM EDT | 8:00 AM PDT | 4:00 PM BST | 5:00 PM CEST

Webinar Date/Time: Tuesday, August 13th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit highlight the potential impact FDA's Diversity Action Plan guidance will have on industry.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

In an interview with ACT editor Andy Studna at DIA 2024, Beakes-Read, head, global regulatory policy and intelligence, Johnson & Johnson Innovative Medicine highlights the integration of technological advancements into drug development and benefits patients are seeing from FDA's Accelerated Approval Program.

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

Webinar Date/Time: Thursday, June 27th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Six trends to help guide trial master file strategy.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

A forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.

Webinar Date/Time: Tuesday, May 21st, 2024 at 2pm PDT | 5pm EDT | 11pm CEST

As adoption increases, regulatory bodies are becoming more involved in the oversight of artificial intelligence.

New amendment explicitly states that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act.

In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.