The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

The agency’s Center for Drug Evaluation and Research expects to receive 200 plans annually, with 40 plans expected to go to the biologics center.

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.