RAPS

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.