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.
Sens. Markey and Brown say they oppose the nomination of Scott Gottlieb to be FDA commissioner because he will not effectively use FDA to battle the n...
Recent Warning Letters show that document control and data integrity remain key concerns of FDA investigators, according to an analysis by AssurX.
FDA approves an Audentes Therapeutics IND for AT132, the companys gene therapy product candidate to treat X-Linked Myotubular Myopathy.
FDA grants an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system.
FDA tells Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the companys BLA for Heplisav-B [...
FDA clears an ETS Wound Care 510(k) for the Mirragen Advanced Wound Matrix for use in treating acute and chronic wounds.