Two K&L Gates attorneys say an FDA Warning Letter gives Abbott 15 days to correct cybersecurity flaws in St. Jude Medical implantable cardiac devices.
CDER director of professional affairs and stakeholder engagement John Whyte says FDA is taking steps to help companies identify demographic subgroups ...
Stakeholders provide comments on and seek changes in FDA draft guidances on communication of regulated product information that is consistent with the...
CytRx Corp. and FDA reach an agreement to allow the company to submit a rolling 505(b)(2) NDA for aldoxorubicin in soft tissue sarcomas.
FDA clears a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo.
Pfizer says it has received grand jury subpoenas relating to a Justice Department probe of three companies that are the sole source for intravenous sa...
Three CDER staffers say that using a target product profile can speed regulatory review times.
FDA concludes a 4/10-18 inspection at Aurobindo Pharmas formulations manufacturing facility in Hyderabad, India that resulted in a six-item Form-483.