Federal Register notice: FDA makes available a draft guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeling.
Federal Register notice: FDA makes available a final guidance entitled Information Requests and Discipline Review Letters Under GDUFA.
A Congressional Budget Office report says that although consumer use of prescription drugs has increased between 2009 and 2018, average spending on dr...
FDA releases an FDA-483 and EIR from a 2019 inspection at Winnipeg, Manitoba-based Emergent BioSolutions Canada.
FDA cautions Hopkinton Drugs about deficiencies in its practices for producing drug products that put patients at risk.
Federal Register notice: FDA announces a 4/12 virtual public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data ...
Federal Register notice: FDA evaluates certain substances that have been nominated for inclusion on a drug compounding list of bulk drug substances fo...
FDA says the pandemic affected its ability to complete regulatory actions for inspected facilities within six months of the inspection closing during ...