The FDA outlined its current thinking for drug sponsors on assessing gastric pH-dependent drug-drug interactions (DDI) in a final guidance released Monday. 

The European Medicines Agency (EMA) has offered recommendations for electronic data collection in clinical trials in a new final guidance.

Sanofi is set to acquire Provention Bio, picking up the company’s first-in-class treatment to delay stage 3 type 1 diabetes (T1D).

The FDA needs to set performance goals and metrics for its advanced drug manufacturing initiative to strengthen the U.S. supply chain, the Government Accountability Office (GAO) said in a report released Friday.

Sen. Bernie Sanders (I-Vt.) and Rep. Cori Bush (D-Mo.) have proposed legislation that would cap the list price of insulin at no more than $20 per vial.

The FDA has decided the postpandemic fate of 72 final guidances published over the past three years to address COVID-19 issues, choosing to withdraw about one-third, phase out another one-third and retain most of the remainder but plan to update them in the near future.

In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.