Regulatory Pathways

Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.

The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.

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.

Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .

Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.

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.

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

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.