The Tufts Center for the Study of Drug Development reports on the growth of contract research services as part of drug development worldwide.
Apotex recalls four lots of drospirenone and ethinyl estradiol tablets because the contraceptive may contain defective blisters with incorrect tablet ...
FDA warns Andapharm about repeat and additional CGMP violations in its manufacturing of finished pharmaceuticals.
National and international ultrasound societies petition FDA to remove a black box warning from ultrasound contrast agent labels.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Informed Consent for In Vitro Diagnostic Device...
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Reagents for Detection of Specific Novel Influe...
Two stakeholders respond positively to an FDA guidance on developing a surrogate endpoint table.
AdvaMed praises two FDA draft guidances on blood glucose test systems.