FDA commissioner Scott Gottlieb unveils a new five-year strategy for the agencys Sentinel System.
FDA sends Akorn a Warning Letter related to a month-long inspection at its Decatur, IL manufacturing facility that was conducted April and May last ye...
FDA approves Grifols Erytra Eflexis, a benchtop analyzer that performs pretransfusion compatibility testing.
FDA grants RadioMedix a fast track designation for its investigational diagnostic radiopharmaceutical, [64] Cu-Dotatate, a positron emission tomograph...
HHS secretary Alex Azar says President Trump will continue to look for ways to force drug companies to lower drug list prices.
FDA denies a Public Citizen petition calling for a clopidogrel Boxed Warning on use for longer than 12 months.
PhRMA asks FDA to give stakeholders significant lead time before implementing a new National Drug Code format.
FDA commissioner Scott Gottlieb unveils agency plans to create a new Office of Drug Evaluation Science to modernize the drug review process.