Due to concern about microbial contamination, Bayer recalls one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles.
A bipartisan group of nine senators ask FDA what it is doing to revise its animal testing regulations to be consistent with the FDA Modernization Act ...
An eastern California federal grand jury returns a three-count indictment against a citizen of China who formerly resided in Clovis, CA, charging him ...
Federal Register notice: FDA announces a public workshop entitled Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Pr...
Federal Register notice: FDA announces a 1/23/24/2024 public meeting entitled Advancing Drug Development for the Prevention of Spontaneous Preterm Bir...
Federal Register final rule: FDA posts a final rule on direct-to-consumer advertisements and a requirement that the major statement must be presented ...
FDA publishes a draft guidance with questions and answers on translating GLP study reports into English.
Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.
