Regulatory

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.

Webinar Date/Time: Wednesday, May 22, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

Webinar Date/Time: Option 1: Thursday, February 1st, 2024 at 9am EST | 6am PST | 2pm GMT | 3pm CET Option 2: Thursday, February 1st, 2024 at 2pm EST | 11am PST | 7pm GMT | 8pm CET

Webinar Date/Time: Wed, Jan 17, 2024 12:00 PM EST

New laws leave consumers unprotected against third parties accessing their genetic data.

Agency will be reorganizing field force and compliance functions.

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.

Cleve talks about the future of the industry and how data remains a key focus.

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.

Webinar Date/Time: Thursday, October 26th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Stepped-up training and real-time application key to avoiding compliance pitfalls.

How to support trial investigators through decentralization of trial elements.

Perceived barriers of DCTs can be quickly overcome to ensure their viability in clinical research.

Webinar Date/Time: Tue, Sep 19, 2023 11:00 AM EDT

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.