FDA biomarker development program co-director Chris Leptak describes three sources of biomarker information FDA can use in regulatory decisions.
Dr. Reddys Laboratories says an FDA-483 raised two new concerns with its Srikakulam API facility.
FDA releases its latest batch of Warning Letters that cite Cassandra E. Curtis, Sanapac Co., and Trone Health Services.
FDA accepts for review an AbbVie a supplemental NDA for Imbruvica (ibrutinib) in chronic graft-versus-host-disease after failure of one or more lines ...
FDA clears a PTS Diagnostics 510(k) to expand the top range for measurement of HDL cholesterol to 120 mg/dL (3.1 mmol/L) for the companys PTS Panels l...
Attorney James Beck describes a North Carolina federal court decision using a three-part test to determine whether a state tort claim against a PMA me...
CDER director Janet Woodcock says the generic drug industry and regulators must stay ahead of six forces that are driving drug development.
Recent Warning Letters show that document control and data integrity remain key concerns of FDA investigators, according to an analysis by AssurX.