RAPS

Reviewers often cannot locate patient experience data, such as clinical outcome assessments and focus group transcripts, in an application or are not clear on why the sponsor expects these data to support a regulatory decision, FDA’s Robyn Bent told the RAPS Convergence 2025 meeting.

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.

Focus of the campaign is the well-established pharmaceutical manufacturing sector, rather than cell and gene therapy production, the US FDA’s principal deputy commissioner said.

In admitting problems, the FDA creates a docket for comments and will convene a public workshop in the spring on why the clinical trial innovation is not more widespread.

Several FDA staffers presented at the RAPS Convergence conference via Zoom and pre-recorded video instead, illustrating that just the threat of a shutdown can scramble FDA plans.

Potential sponsors have many questions to answer, but have a unique opportunity to influence policy for a new therapy area.

The vast majority of meeting requests eligible for the in-person/virtual format were not requested as such, according to Center for Drug Evaluation and Research data.

New guidance is due in a few months that should answer questions about how the FDA will react if a sponsor does not reach its clinical trial diversity goals.

Experts wonder why the FDA Commissioner commented on a system seemingly working fine, but Califf says it is necessary to remember the potential conflict between the two roles.

In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.

US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.

Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.