The Senate HELP Committee added a therapeutic equivalence provision to the draft measure it floated two weeks ago. The bill introduced in the Senate still does not include provisions on clinical trial diversity or 180-day exclusivity.
The Senate user fee reauthorization bill would enable sponsors to get a therapeutic equivalence rating for products approved under the 505(b)(2) pathway rather than go through the onerous process of filing a citizen petition.
Senate Health, Education, Labor and Pensions Committee chair Patty Murray, D-WA, and ranking member Richard Burr, R-NC, introduced the
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.
A lack of process documentation was part of the reason the FDA forgot to account for fee refunds in its estimates of incoming applications for two fiscal years, a mistake that likely cost the agency millions in revenue.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
